FDA product code FEN: Device, Cystometric, Hydraulic
FEN is the FDA product code for device, cystometric, hydraulic. It is a Class II device, regulated under 21 CFR 876.1620 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 36 510(k) submissions under FEN, from 21 different applicants. The average 510(k) review took 129 days (median 90). FDA has posted 3 recalls for FEN devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Cystometric, Hydraulic |
| Device class | Class II |
| Regulation | 21 CFR 876.1620 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for FEN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 105 |
Compare with all 510(k) review times · Search every FEN clearance
Top FEN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fiberoptic Sensor Technlogies, Inc. | 8 | 1995-05-11 |
| Life-Tech Intl., Inc. | 5 | 1995-11-30 |
| Medamicus, Inc. | 3 | 1997-06-03 |
| Laborie Medical Technologies, Ltd. | 2 | 1995-07-06 |
| Rusch Intl. | 2 | 1995-06-15 |
16 more applicants have FEN clearances. See the full list in Caduvo.
Most recent FEN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212830 | Srs Medical | CT3000Pro | 2021-12-21 | 105 |
| K082701 | Urodynamix Technologies, Ltd. | URONIRS, MODEL 2000 | 2008-12-18 | 93 |
| K073552 | Laborie Medical Technologies, Corp. | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY | 2008-03-05 | 78 |
| K001386 | Pelvicare, Inc. | ACCUSET SENSOR, MODEL 2000 | 2000-07-17 | 76 |
| K992715 | Medtronic Functional Diagnostics A/S | NEURO URODYNAMIC SUITE, MODEL 9032E0101 | 2000-02-28 | 200 |
Recalls for FEN devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-07-17.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code FEN?
FEN is the FDA product code for device, cystometric, hydraulic. It is a Class II device, regulated under 21 CFR 876.1620 and reviewed by the Gastroenterology and Urology panel.
What device class is FEN?
Class II, regulation 21 CFR 876.1620. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FEN?
Across 36 cleared submissions the average was 129 days from receipt to decision (median 90).
Which companies have the most FEN clearances?
Fiberoptic Sensor Technlogies, Inc. (8); Life-Tech Intl., Inc. (5); Medamicus, Inc. (3); Laborie Medical Technologies, Ltd. (2); Rusch Intl. (2).
Have FEN devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2019-07-17.
Next steps
- Run an FDA pathway report with predicate devices for product code FEN
- Run a recall and safety report across every FEN manufacturer
- Watch product code FEN 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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