FDA product code KOE: Dilator, Urethral
KOE is the FDA product code for dilator, urethral. It is a Class II device, regulated under 21 CFR 876.5520 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 27 510(k) submissions under KOE, from 16 different applicants. The average 510(k) review took 124 days (median 85). FDA has posted 3 recalls for KOE devices.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Urethral |
| Device class | Class II |
| Regulation | 21 CFR 876.5520 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for KOE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 255 |
Compare with all 510(k) review times · Search every KOE clearance
Top KOE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Medical Systems, Inc. | 4 | 1992-10-28 |
| Vance Products, Inc. | 4 | 1981-07-10 |
| Atrion Medical Products, Inc. | 2 | 2004-03-03 |
| Cook Urological, Inc. | 2 | 1996-10-18 |
| Advanced Surgical Intervention, Inc. | 2 | 1990-08-27 |
11 more applicants have KOE clearances. See the full list in Caduvo.
Most recent KOE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191061 | Urotronic, Inc. | Optilume Basic Urological Balloon Dilation Catheter | 2020-01-02 | 255 |
| K032840 | Atrion Medical Products, Inc. | ATRION MEDICAL QL INFLATION DEVICE | 2004-03-03 | 174 |
| K972964 | Atrion Medical Products, Inc. | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | 1997-10-10 | 60 |
| K962611 | Ryder Intl. Corp. | BARD EAGLE INFLATION DEVICE | 1996-10-21 | 110 |
| K961904 | Cook Urological, Inc. | AQ HYDROPHILIC DILATORS | 1996-10-18 | 155 |
Recalls for KOE devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-01-04.
| Year | Recalls |
|---|---|
| 2019 | 2 |
Frequently asked questions
What is FDA product code KOE?
KOE is the FDA product code for dilator, urethral. It is a Class II device, regulated under 21 CFR 876.5520 and reviewed by the Gastroenterology and Urology panel.
What device class is KOE?
Class II, regulation 21 CFR 876.5520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KOE?
Across 27 cleared submissions the average was 124 days from receipt to decision (median 85).
Which companies have the most KOE clearances?
American Medical Systems, Inc. (4); Vance Products, Inc. (4); Atrion Medical Products, Inc. (2); Cook Urological, Inc. (2); Advanced Surgical Intervention, Inc. (2).
Have KOE devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2019-01-04.
Next steps
- Run an FDA pathway report with predicate devices for product code KOE
- Run a recall and safety report across every KOE manufacturer
- Watch product code KOE 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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