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General product information only, not medical advice. This page does not cover insertion, balloon inflation or any clinical decision; follow the manufacturer’s instructions for use (IFU) and the directions of a licensed clinician.
Short answer: a Foley-type catheter has two separate size numbers. The French (Fr) number describes the shaft, and the balloon has its own labeled fill volume in cc or mL. In the U.S. device records below the labeled balloon volumes are 3, 5, 10 and 30 cc, and a few products are labeled with a range such as 5-10 mL. The product label, not this page, is the reference for any specific catheter.
Catheter balloon size chart
Every row is a record in the FDA’s Global Unique Device Identification Database (GUDID), available through the openFDA device UDI API (date checked 2026-10-30). Brand, model and company are as listed in the record; this is a sample of labeled products, not a complete list of what exists.
| Product (model) | Company | Balloon volume as labeled | Shaft size | Other record details |
|---|---|---|---|---|
| Dover 100% silicone Foley, pediatric (8888760310) | Cardinal Health 200 | 3 cc | 10 Fr (3.3 mm) | 2-way; not labeled as natural rubber latex |
| Bardex Lubricath Pediatric Foley (0165PL10) | C. R. Bard | 3 cc | 10 Fr | Labeled as containing natural rubber latex |
| TruCath temperature-sensing Foley (TS1005) | HR Pharmaceuticals | 5 mL | 10 Fr | Silicone, 2-way |
| Dover 100% silicone Foley (8887605148) | Cardinal Health | Named “5-10 mL”; total volume field 5 mL | 14 Fr | 2-way |
| McKesson silicone Foley, coudé tip (16-SFOL512C) | McKesson Medical-Surgical | 5-10 cc | 12 Fr | 16 inch length in description |
| Dover 100% silicone Foley (8887605303) | Cardinal Health 200 | 5 cc | 30 Fr (10.0 mm) | 2-way |
| TruCath temperature-sensing Foley (TS1610) | HR Pharmaceuticals | 10 mL | 16 Fr | Silicone, 2-way |
| Dover silicone oil coated latex Foley (3607) | Cardinal Health 200 | 30 cc | 18 Fr (6.0 mm) | 2-way; labeled as containing natural rubber latex |
| Bardex Lubri-Sil all-silicone Foley (176818) | C. R. Bard | 30 cc | 18 Fr | Lubricious coated, all silicone |
| Bardex Lubri-Sil I.C. all-silicone Foley (1768SI24) | C. R. Bard | 30 cc | 24 Fr | All silicone, coated |
All records listed are sterile, single-use and prescription (Rx) devices. Check your product’s labelling: the volume printed on the catheter, its balloon-port marking and its package are what apply to that product.
How to read the chart
Fr is the shaft, cc is the balloon
The Fr number is the catheter’s outer size. The balloon volume is a separate figure, so the chart shows 10 Fr catheters with 3 cc and 5 mL balloons, a 16 Fr catheter with a 10 mL balloon and 18 Fr catheters with 30 cc balloons. Neither number can be derived from the other.
Balloon port and 2-way versus 3-way names
The balloon port (also called the inflation port or valve) is the small side channel connected to the balloon, separate from the drainage lumen. In product names, “2-way” means drainage plus the balloon port, and “3-way” adds a third channel for irrigation. The records above are all 2-way. The existing Foley catheter guide describes the parts in plain language.
Balloon capacity versus labeled volume
“Foley catheter balloon capacity” and “balloon size” are used for the same labeled figure in search, but the label states the volume for that product, and some products state a range (5-10 cc) instead of a single number. This page does not give inflation volumes or technique.
Equivalence notes
- cc and mL: the records use “cc” and “mL” for balloon volume interchangeably (for example “5 ml” in one TruCath record, “5 CC” in a Dover record).
- Fr to mm: where a record gives millimetres, it equals Fr divided by 3: 10 Fr = 3.3 mm, 18 Fr = 6.0 mm, 30 Fr = 10.0 mm.
- Fr and Ch: a Dover tray record writes “Fr/Ch”, treating French and Charrière as the same scale. For other catheter families see suprapubic catheter sizes and council tip catheter sizes.
Common mix-ups
- Treating Fr as balloon size. A 30 Fr catheter and a 30 cc balloon are unrelated figures; the chart shows a 5 cc balloon on a 30 Fr shaft.
- Assuming one balloon volume per catheter type. Labeled volumes in these records range from 3 to 30 cc, with some ranges.
- Pediatric means 3 cc. Two pediatric-labeled 10 Fr records list 3 cc, but another 10 Fr record in the chart lists 5 mL. Read each label.
- Ignoring material labeling. Latex labeling differs by record: two rows above are labeled as containing natural rubber latex and the silicone rows are not.
Regulatory context
Under 21 CFR 876.5130 (urological catheters and accessories), the FDA’s identification of the device type includes “balloon retention type catheters” and the classification is Class II (see Sources, date checked 2026-10-30). The GMDN term for a Foley-type device (code 34917) describes a flexible tube with an inflatable balloon at its distal tip, intended to be introduced by a healthcare professional and to be single-use. For wider context see the urinary catheter types guide and the urology clinic supply checklist. Catalogue references for catheters, urology and incontinence supplies are on lac.us.
FAQ
What are the standard Foley catheter balloon sizes?
The GUDID records in the chart list balloon volumes of 3 cc, 5 cc or mL, 10 mL and 30 cc, plus products labeled 5-10 cc. Which one applies to a given catheter is stated on that catheter’s label.
Is the balloon size the same as the French size?
No. French describes the shaft; the balloon has its own labeled volume.
What is a catheter balloon port?
It is the side port connected to the balloon channel, separate from the drainage channel. In product names, 2-way means drainage and balloon port; 3-way adds irrigation.
Is cc the same as mL?
Yes. The records use both for the same labeled volume.
Sources
Date checked for all sources: 2026-10-30.
- FDA Global Unique Device Identification Database via the openFDA device UDI API: https://api.fda.gov/device/udi.json. The same records appear on AccessGUDID: https://accessgudid.nlm.nih.gov/.
- 21 CFR 876.5130, Urological catheter and accessories: https://www.law.cornell.edu/cfr/text/21/876.5130.
- GMDN term 34917 (indwelling urethral drainage balloon catheter), definition as shown in AccessGUDID device records: https://accessgudid.nlm.nih.gov/devices/00801741077906.
