FDA product code KNY: Accessories, Catheter, G-U
KNY is the FDA product code for accessories, catheter, g-u. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 65 510(k) submissions under KNY, 1 in the last five years, from 50 different applicants. The average 510(k) review took 105 days (median 78); 139 days on average over the last three years. FDA has posted 3 recalls for KNY devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Catheter, G-U |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KNY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 191 |
| 2018 | 1 | 30 |
| 2026 | 1 | 139 |
Compare with all 510(k) review times · Search every KNY clearance
Top KNY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Promepla Sam | 3 | 2018-09-07 |
| Solace Therapeutics | 3 | 2017-03-02 |
| Percutaneous Systems, Inc. | 3 | 2005-09-22 |
| Lake Region Mfg., Inc. | 3 | 1998-06-05 |
| Avail Medical Products, Inc. | 2 | 2011-09-08 |
45 more applicants have KNY clearances. See the full list in Caduvo.
Most recent KNY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260919 | Class Medical , Ltd. | Transurethral Catheter Safety Valve (TUCSV) (80050) | 2026-08-05 | 139 |
| K182144 | Promepla Sam | Bi-Flex Evo | 2018-09-07 | 30 |
| K162356 | Solace Therapeutics | Vesair Cystoscopic Sheath | 2017-03-02 | 191 |
| K140441 | Promepla Sam | BI-FLEX URETERAL ACCESS SHEATH | 2014-06-17 | 116 |
| K140562 | Leomed, LLC | WIJAY EZ-VOID EXTERNAL CATHETER VALVE | 2014-06-16 | 103 |
Recalls for KNY devices
3 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-09-11.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code KNY?
KNY is the FDA product code for accessories, catheter, g-u. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is KNY?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNY?
Across 65 cleared submissions the average was 105 days from receipt to decision (median 78).
Which companies have the most KNY clearances?
Promepla Sam (3); Solace Therapeutics (3); Percutaneous Systems, Inc. (3); Lake Region Mfg., Inc. (3); Avail Medical Products, Inc. (2).
Have KNY devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2024-09-11.
Next steps
- Run an FDA pathway report with predicate devices for product code KNY
- Run a recall and safety report across every KNY manufacturer
- Watch product code KNY 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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