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This page describes products and general use; it is not medical advice.
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An irrigation catheter is a flexible tube used to introduce nondrug fluid into a body cavity and, usually, to let that fluid drain back out. In US regulatory terms it is not one product with one class: FDA files several different device codes under irrigation, and the commonest bladder version is simply a Foley catheter with an extra channel. This page sorts out which is which. It is written for clinic staff, buyers and students, and it does not give procedure steps, because irrigating a catheter is a clinician-ordered procedure.
What an irrigation catheter is
Under 21 CFR 878.4200, an introduction/drainage catheter is “a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions,” and the regulation lists irrigation and drainage catheters among its examples (read 2026-11-07, 21 CFR 878.4200). Searches such as “irrigated catheter”, “irrigating catheter” and “catheter irrigation” mix two meanings: the device (the catheter that carries irrigation fluid) and the act (flushing through a catheter). This page covers the device. The act is a clinical procedure.
Who uses it: clinicians in urology, surgery and gastroenterology settings, and the staff who stock supplies for them.
How it is built
Most irrigation catheters are single- or multilumen tubes. A urinary Foley catheter has a drainage lumen and a balloon-inflation lumen; the 3-way version adds a third channel that can carry fluid in while the drainage lumen carries it out. See catheter lumen and parts of a catheter for the lumen and balloon anatomy, and 3-way Foley catheters for the third channel. One Foley IFU describes its catheter as latex or silicone and single use, with a latex-allergy warning (Mais India Foley Balloon Catheter IFU, ed. 02 rev. 02, 20.05.2026).
Types and FDA classification
The table is built from the openFDA device classification database (read 2026-11-07) and the CFR sections it cites.
| FDA product code and name | Class | Regulation | Where it fits |
|---|---|---|---|
| GBX Catheter, Irrigation | 1 | 21 CFR 878.4200 | General introduction/drainage catheter; 510(k)-exempt in the regulation |
| GBQ Catheter, Continuous Irrigation | 1 | 21 CFR 878.4200 | Continuous-irrigation code under the same regulation |
| KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 2 | 21 CFR 876.5980 | Gastrointestinal tube and accessories for instilling and withdrawing fluids |
| PRS Gastric Colonic Catheter Irrigation Kit | 2 | 21 CFR 876.5980 | Convenience kit under FDA’s convenience-kit policy |
| GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 2 | 21 CFR 876.5010 | Biliary catheter (see extraction balloon) |
| PTT Biliary Catheter For Irrigation And Contrast Injection, Exempt | 2 (exempt) | 21 CFR 876.5010 | Biliary catheter, exempt |
| SCT Foley Catheters And Accessories With Additional Safety Features; PPB Foley Catheter Kit | 2 | 21 CFR 876.5130 | Urological catheters, the regulation that covers bladder irrigation use |
The bladder case
21 CFR 876.5130 defines a urological catheter as a “flexible tubular device inserted through the urethra and used to pass fluids to or from the urinary tract,” and it includes balloon retention, coude, straight and ureteral types and a gastro-urological irrigation tray for urological use (read 2026-11-07, 21 CFR 876.5130). A catheter used for bladder irrigation is therefore a Foley-type urological catheter, Class II, not a separate “irrigation catheter” class. One manufacturer IFU states the product “is used for the drainage of urine from urinary bladder and also used for irrigation of bladder” (Mais India, above). Another describes its 2-way and 3-way series as a “urinary catheter to pass fluids to and from the urinary bladder” (Fortune Medical Instrument Corp. IFU UM0101 V17). That IFU gives a shorter stated use period for one 3-way product (up to 29 days) than for one 2-way product (up to 90 days), so the labeling of the exact product governs.
Open and closed systems, and irrigation sets
Open-system and continuous irrigation are clinical techniques, not separate device classes. Syringes, trays and kits that accompany a catheter are covered in the syringe guide and, for wounds, the wound irrigation supplies guide.
How to choose
The sources read give no general selection rule. What they do establish is where the facts sit: intended use, material (latex or silicone), single-use status and stated duration of use are on the manufacturer’s IFU, and the clinician’s order determines the product. For urinary catheter categories see the urinary catheter types guide.
Safe use and handling basics
- Read the IFU for the exact product. Contraindications listed in one Foley IFU include urethral trauma, strictures and active infection at the insertion site (Mais India, above).
- Check latex-allergy warnings before selecting a latex product.
- Routine bladder irrigation is not part of standard catheter maintenance in the site’s CAUTI prevention bundle summary.
Common mistakes
- Assuming “irrigation catheter” is a single FDA class. The table spans Class 1 and Class 2 codes under four regulations.
- Confusing the device with the procedure. A product listing is not an instruction for how to irrigate.
- Treating a 3-way Foley as a different regulated product from a Foley. Under 876.5130 it is a Foley-type urological catheter.
FAQ
Is normal saline or sterile water better for bladder irrigation?
No source read here ranks them. The clinical literature describes manual irrigation with either sterile water or normal saline through a Foley catheter for clot retention and hematuria (J Endourol 2009, PubMed 19594375, abstract). Which fluid is used is the ordering clinician’s decision.
What are the four types of catheters?
There is no single official count. A common grouping for urinary catheters is indwelling (Foley), intermittent and external, described in the urinary catheter types guide. Regulators also sort catheters by regulation, for example 878.4200 versus 876.5130 above.
How do you flush a Foley catheter?
Flushing or irrigating a Foley catheter is a clinician-ordered procedure, and this page does not give steps. Follow the facility protocol, the order and the product IFU. The Foley catheter guide explains the device.
Why would someone need a Foley catheter?
Manufacturer IFU wording gives short-term urine drainage and bladder wash, with stated benefits such as relieving urinary retention, measuring urine output in critical care and use during or after surgery (Mais India, above). Whether a patient needs one is a clinical decision.
Sources
- openFDA device classification database, https://api.fda.gov/device/classification.json (read 2026-11-07)
- 21 CFR 878.4200, 876.5130, 876.5980 via Cornell LII (read 2026-11-07)
- Mais India Foley Balloon Catheter IFU ed. 02 rev. 02, https://www.maisindia.com/wp-content/uploads/2026/05/IFU-Foley-Balloon-Catheter.pdf (read 2026-11-07)
- Fortune Medical Instrument Corp. Silicone 2-Way (3-Way) Foley Balloon Catheter IFU UM0101 V17, https://res.onemed.com/DK/IU/944764.pdf (read 2026-11-07)
- PubMed 19594375, J Endourol 2009 (abstract, read 2026-11-07)
