FDA product code EXR: Urinometer, Mechanical
EXR is the FDA product code for urinometer, mechanical. It is a Class II device, regulated under 21 CFR 876.1800 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 9 510(k) submissions under EXR, from 8 different applicants. The average 510(k) review took 98 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Urinometer, Mechanical |
| Device class | Class II |
| Regulation | 21 CFR 876.1800 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EXR clearance
Top EXR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Brother Scientific Products, Inc. | 2 | 1977-06-03 |
| Key Medical Services, Inc. | 1 | 1994-05-17 |
| Puritas Health Care, Inc. | 1 | 1993-12-17 |
| Kendall Healthcare Products Co. Div.Of Tyco Health | 1 | 1991-04-25 |
| Unoplast A/S | 1 | 1990-11-02 |
3 more applicants have EXR clearances. See the full list in Caduvo.
Most recent EXR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934142 | Key Medical Services, Inc. | URINARY DRAINAGE BAG | 1994-05-17 | 265 |
| K935578 | Puritas Health Care, Inc. | URINE METER | 1993-12-17 | 29 |
| K911258 | Kendall Healthcare Products Co. Div.Of Tyco Health | KENDALL PEDIATRIC URINE METER | 1991-04-25 | 34 |
| K896732 | Unoplast A/S | UNOMETER 500 | 1990-11-02 | 337 |
| K870240 | Fraass Survival Systems, Inc. | COMPRESS AND SKULLCAP, HEAD DRESSING | 1987-02-20 | 30 |
Recalls for EXR devices
openFDA lists no recalls for product code EXR.
Frequently asked questions
What is FDA product code EXR?
EXR is the FDA product code for urinometer, mechanical. It is a Class II device, regulated under 21 CFR 876.1800 and reviewed by the Gastroenterology and Urology panel.
What device class is EXR?
Class II, regulation 21 CFR 876.1800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EXR?
Across 9 cleared submissions the average was 98 days from receipt to decision (median 34).
Which companies have the most EXR clearances?
Brother Scientific Products, Inc. (2); Key Medical Services, Inc. (1); Puritas Health Care, Inc. (1); Kendall Healthcare Products Co. Div.Of Tyco Health (1); Unoplast A/S (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EXR
- Run a recall and safety report across every EXR manufacturer
- Watch product code EXR 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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