FDA product code FFG: Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
FFG is the FDA product code for device, urine flow rate measuring, non-electrical, disposable. It is a Class II device, regulated under 21 CFR 876.1800 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 17 510(k) submissions under FFG, from 15 different applicants. The average 510(k) review took 84 days (median 78). FDA has posted 1 recall for FFG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable |
| 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 FFG clearance
Top FFG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vital Metrics, Inc. | 3 | 1985-01-03 |
| Laytech Medical Co. | 1 | 1989-08-11 |
| Medical Engineering Corp. | 1 | 1989-02-08 |
| Eris Medical Technology | 1 | 1985-04-22 |
| Epcom Medical Systems, Inc. | 1 | 1985-02-25 |
10 more applicants have FFG clearances. See the full list in Caduvo.
Most recent FFG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893827 | Laytech Medical Co. | PEAK FLOW RATE METER | 1989-08-11 | 79 |
| K883274 | Medical Engineering Corp. | SURGITEK (R) UROFLOW SYSTEM | 1989-02-08 | 189 |
| K850169 | Eris Medical Technology | ERIS URO-DIAGNOSTIC SYSTEM | 1985-04-22 | 96 |
| K844338 | Epcom Medical Systems, Inc. | 1URO-LOG HOME DIAGNOSTIC PACK | 1985-02-25 | 109 |
| K843442 | Vital Metrics, Inc. | URINARY DRAINAGE CONTAINER 2013 WITH | 1985-01-03 | 121 |
Recalls for FFG devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-12-04.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code FFG?
FFG is the FDA product code for device, urine flow rate measuring, non-electrical, disposable. It is a Class II device, regulated under 21 CFR 876.1800 and reviewed by the Gastroenterology and Urology panel.
What device class is FFG?
Class II, regulation 21 CFR 876.1800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFG?
Across 17 cleared submissions the average was 84 days from receipt to decision (median 78).
Which companies have the most FFG clearances?
Vital Metrics, Inc. (3); Laytech Medical Co. (1); Medical Engineering Corp. (1); Eris Medical Technology (1); Epcom Medical Systems, Inc. (1).
Have FFG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-12-04.
Next steps
- Run an FDA pathway report with predicate devices for product code FFG
- Run a recall and safety report across every FFG manufacturer
- Watch product code FFG 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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