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This page describes products and general use; it is not medical advice.
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An inline suction catheter, also called a closed suction catheter, is a tracheobronchial suction catheter supplied as a closed system, the alternative to an open single-use catheter. This guide covers how US regulators classify the device, how closed and open systems compare in published trials, and where the catheter sits among related suction equipment.
What an inline (closed) suction catheter is
Under US federal regulation, a tracheobronchial suction catheter is “a device used to aspirate liquids or semisolids from a patient’s upper airway” (21 CFR 868.6810(a), checked 2026-11-01). An inline or closed suction catheter is that device offered as a closed system; the clinical literature uses “closed” and “open” to name the two system types and compares them directly. Use on a patient is covered by the manufacturer’s instructions for use and facility protocols, not by this page.
Where it appears: the studies cited below were run in adult and paediatric intensive care units with mechanically ventilated patients.
Regulatory identity: class, product codes and examples
The FDA lists suction catheters of this type as Class 1 (general controls) and exempt from 510(k) premarket notification, subject to the limitations in 21 CFR 868.9 (21 CFR 868.6810(b), checked 2026-11-01). The openFDA device classification database (data last updated 2026-10-19, checked 2026-11-01) groups related products under the same regulation number, 868.6810:
| FDA product code | Name in the FDA database | Class |
|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | 1 |
| OFR | Tracheobronchial Suction Catheter Kit | 1 |
| OFS | Tracheal Suction Set | 1 |
| OFO | Airway Suction Kit | 1 |
| NQV | Catheter, Suction, Tracheobronchial, Reprocessed | 1 |
| OYI | Non-Bronchoscopic Bronchoalveolar Lavage Catheter | 1 |
Closed systems are a recognised type within product code BSY. The openFDA 510(k) database (checked 2026-11-01) returns eight BSY records with “closed” in the device name, among them K944251 (Kendall Modu-Vac Closed Suction System, decision 1994-09-21), K955831 (Argyle Aspr-Care Closed Suction System, 1996-03-28), K972258 (Hi-Care Closed Suction System, 1997-12-29) and K031997 (Mallinckrodt Dar Ty-Care and Ty-Care Exel Closed Suction System, 2003-11-25). These records show the device type exists in FDA’s files; they say nothing about which products are sold today.
Closed versus open systems: what the trials found
Published pooled analyses give a mixed picture. In short: across adult intensive care trials, closed systems did not lower ventilator-associated pneumonia (VAP) or death compared with open systems, and the evidence does not support preferring one over the other on those outcomes.
| Source | Population and design | VAP and mortality | Other findings |
|---|---|---|---|
| Jongerden et al., Crit Care Med 2007 (PMID 17133187) | Meta-analysis of 15 randomised trials, adult ICU | No significant difference in VAP (8 studies, 1,272 patients) or mortality (4 studies, 1,062 patients) | Closed systems: smaller changes in heart rate (weighted mean difference -6.33; 95% CI -10.80 to -1.87) and in mean arterial pressure (SMD -0.43; CI -0.87 to 0.00); more colonisation (2 studies, 126 patients; RR 1.51, CI 1.12-2.04). Authors: no evidence to prefer closed over open. |
| Siempos et al., Br J Anaesth 2008 (PMID 18250225) | Meta-analysis of 9 randomised trials | VAP OR 0.96 (CI 0.72-1.28); mortality OR 1.04 (CI 0.78-1.39) | Closed systems: longer mechanical ventilation (WMD 0.65 days, CI 0.28-1.03) and higher respiratory-tract colonisation (OR 2.88, CI 1.50-5.52). Authors: no benefit for VAP, mortality or ICU stay. |
| Morrow et al., Pediatr Crit Care Med 2012 (PMID 21283045) | Prospective, non-randomised controlled study in a paediatric intensive care unit in South Africa (250 patients; suction systems alternated monthly) | VAP 20.5% closed vs 23.3% open (p = 0.6) | Closed-system suctioning did not affect VAP frequency or patient outcome in this setting. |
Abstracts checked on PubMed, 2026-11-01. These are pooled results from specific trials and populations; they are not a recommendation for any individual facility or patient.
Where the catheter fits in a suction setup
The catheter is one part of a larger suction pathway. Related CASRAI product guides cover the neighbouring parts: the suction canister that collects aspirated material, the vacuum regulator that sets the source level, the Yankauer suction tool, another suction device, and the whistle-tip catheter, a catheter tip style. For the airway device these catheters are often used with, see tracheostomy tubes.
Types and variants
| Variant | What the sources say |
|---|---|
| Closed (inline) system | Named as such in FDA 510(k) records under product code BSY; compared with open systems in the trials above. |
| Open single-use catheter | The comparator in the trials above; same regulation, 21 CFR 868.6810. |
| Kits and sets | FDA product codes OFR, OFS and OFO cover suction catheter kits and sets under the same regulation. |
| Reprocessed catheters | FDA product code NQV covers reprocessed tracheobronchial suction catheters. |
Safe use and handling basics
- The manufacturer’s instructions for use for the specific product govern its handling; this page gives no procedural guidance.
- The device is regulated by FDA: product labelling carries single-use or reprocessing statements, and FDA lists reprocessed catheters under their own product code (NQV).
- Use of the device sits within facility protocols and clinician direction.
Common mistakes
- Assuming a closed system lowers pneumonia rates. The pooled trials above found no VAP difference between closed and open systems.
- Treating a 510(k) record as proof a product is currently sold. The records are historical decisions; confirm current products with the supplier.
Frequently asked questions
What is a closed suction catheter?
It is a tracheobronchial suction catheter supplied as a closed system, the counterpart to an open single-use catheter. FDA regulates the device type under 21 CFR 868.6810 as Class 1 (checked 2026-11-01).
Are suction catheters for tracheostomy the same as inline catheters?
The FDA regulation for tracheobronchial suction catheters, 21 CFR 868.6810, is written around aspiration from the upper airway. Whether a given product is closed or open, and which airway it is intended for, is stated in its labelling and instructions for use.
Do closed suction systems reduce ventilator-associated pneumonia?
In two meta-analyses of adult ICU trials, no: VAP odds ratio 0.96 (CI 0.72-1.28) in Siempos 2008, and no significant difference in Jongerden 2007. A non-randomised paediatric study in South Africa (Morrow 2012) also found no difference in VAP frequency (20.5% closed vs 23.3% open, p = 0.6).
Does FDA require 510(k) clearance for these catheters?
The classification regulation exempts Class 1 tracheobronchial suction catheters from 510(k), subject to 21 CFR 868.9.
Sources
All sources below were checked on 2026-11-01.
- 21 CFR 868.6810, Tracheobronchial suction catheter, https://www.law.cornell.edu/cfr/text/21/868.6810 (checked 2026-11-01).
- openFDA device classification and 510(k) APIs, https://api.fda.gov/device/classification.json (checked 2026-11-01).
- Jongerden IP et al. Crit Care Med 2007, PubMed 17133187, https://pubmed.ncbi.nlm.nih.gov/17133187/ (checked 2026-11-01).
- Siempos II et al. Br J Anaesth 2008, PubMed 18250225, https://pubmed.ncbi.nlm.nih.gov/18250225/ (checked 2026-11-01).
- Morrow BM et al. Pediatr Crit Care Med 2012, PubMed 21283045, https://pubmed.ncbi.nlm.nih.gov/21283045/ (checked 2026-11-01).
