FDA product code KOB: Catheter, Suprapubic (And Accessories)
KOB is the FDA product code for catheter, suprapubic (and accessories). It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 32 510(k) submissions under KOB, 1 in the last five years, from 26 different applicants. The average 510(k) review took 98 days (median 71); 253 days on average over the last three years. FDA has posted 66 recalls for KOB devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Suprapubic (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 876.5090 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KOB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 90 |
| 2019 | 1 | 267 |
| 2024 | 1 | 253 |
Compare with all 510(k) review times · Search every KOB clearance
Top KOB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Incorporated | 3 | 2019-01-18 |
| Rusch, Inc. | 2 | 1997-02-07 |
| Cook Urological, Inc. | 2 | 1995-08-18 |
| Van-Tec, Inc. | 2 | 1987-03-10 |
| Vance Products, Inc. | 2 | 1981-03-20 |
21 more applicants have KOB clearances. See the full list in Caduvo.
Most recent KOB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240514 | Applied Medical Technology, Inc. | AMT Low-Profile Suprapubic Catheter & Drainage Set | 2024-11-01 | 253 |
| K181097 | Cook Incorporated | Cook Cystostomy Catheter Set | 2019-01-18 | 267 |
| K182709 | Cook Incorporated | One-Step Suprapubic Introducer | 2018-12-26 | 90 |
| K182066 | Cook Incorporated | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | 2018-10-30 | 90 |
| K132890 | Mediplus , Ltd. | SUPRAPUBIC CATHETER AND INTRODUCER SET | 2014-01-17 | 123 |
Recalls for KOB devices
66 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-04-22.
| Year | Recalls |
|---|---|
| 2019 | 4 |
Frequently asked questions
What is FDA product code KOB?
KOB is the FDA product code for catheter, suprapubic (and accessories). It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the Gastroenterology and Urology panel.
What device class is KOB?
Class II, regulation 21 CFR 876.5090. Typical premarket route: 510(k).
How long does a 510(k) take for product code KOB?
Across 32 cleared submissions the average was 98 days from receipt to decision (median 71).
Which companies have the most KOB clearances?
Cook Incorporated (3); Rusch, Inc. (2); Cook Urological, Inc. (2); Van-Tec, Inc. (2); Vance Products, Inc. (2).
Have KOB devices been recalled?
Yes: 66 product recalls across 3 recall events; the most recent began 2019-04-22.
Next steps
- Run an FDA pathway report with predicate devices for product code KOB
- Run a recall and safety report across every KOB manufacturer
- Watch product code KOB 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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