FDA product code KNX: Collector, Urine, (And Accessories) For Indwelling Catheter
KNX is the FDA product code for collector, urine, (and accessories) for indwelling catheter. It is a Class II device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 206 510(k) submissions under KNX, from 112 different applicants. The average 510(k) review took 60 days (median 46). FDA has posted 21 recalls for KNX devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Collector, Urine, (And Accessories) For Indwelling Catheter |
| Device class | Class II |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KNX clearance
Top KNX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio D Corp. | 9 | 1980-12-18 |
| The Kendal Co. | 6 | 1989-06-23 |
| Conphar, Inc. | 6 | 1979-09-07 |
| Convatec, A Division of E.R. Squibb & Sons | 5 | 1995-08-15 |
| Coloplast A/S | 5 | 1987-06-10 |
107 more applicants have KNX clearances. See the full list in Caduvo.
Most recent KNX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110518 | Future Path Medical, LLC | IBAG | 2011-06-24 | 121 |
| K973364 | Maersk Medical A/S | 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG | 1998-03-17 | 190 |
| K972887 | Medline Industries, Inc. | MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG | 1997-12-11 | 128 |
| K971271 | Urology Research Intl., Inc. | BESECURE EXTERNAL URINARY COLLECTION SYSTEM | 1997-08-18 | 136 |
| K971929 | Amsino Intl., Inc. | AMSINO URINARY LEG BAG | 1997-08-06 | 71 |
Recalls for KNX devices
21 product recalls in 11 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-06-25.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
| 2023 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code KNX?
KNX is the FDA product code for collector, urine, (and accessories) for indwelling catheter. It is a Class II device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is KNX?
Class II, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KNX?
Across 206 cleared submissions the average was 60 days from receipt to decision (median 46).
Which companies have the most KNX clearances?
Bio D Corp. (9); The Kendal Co. (6); Conphar, Inc. (6); Convatec, A Division of E.R. Squibb & Sons (5); Coloplast A/S (5).
Have KNX devices been recalled?
Yes: 21 product recalls across 11 recall events; the most recent began 2026-06-25.
Next steps
- Run an FDA pathway report with predicate devices for product code KNX
- Run a recall and safety report across every KNX manufacturer
- Watch product code KNX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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