FDA product code FAP: Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
FAP is the FDA product code for cystometric gas (carbon-dioxide) on hydraulic device. It is a Class II device, regulated under 21 CFR 876.1620 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 85 510(k) submissions under FAP, from 39 different applicants. The average 510(k) review took 116 days (median 78). FDA has posted 6 recalls for FAP devices.
Classification
| Field | Value |
|---|---|
| Device name | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device |
| Device class | Class II |
| Regulation | 21 CFR 876.1620 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Top FAP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Life-Tech Intl., Inc. | 14 | 1993-11-18 |
| Browne Medical Systems, Inc. | 7 | 1992-04-10 |
| Browne Corp. | 7 | 1979-12-06 |
| Dantec Medical, Inc. | 6 | 1992-01-23 |
| Warne Surgical Products, Ltd. | 4 | 1985-05-17 |
34 more applicants have FAP clearances. See the full list in Caduvo.
Most recent FAP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113771 | Neurovision Medical Products, Inc. | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | 2012-12-13 | 357 |
| K974775 | Airtronic Services, Inc. | SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE | 1998-02-19 | 59 |
| K963330 | Synectics Medical, Inc. | URODYNAMIC ANALYSIS MODULE | 1997-04-03 | 223 |
| K962472 | Rusch Intl. | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER | 1996-08-27 | 63 |
| K931175 | Sandhill Scientific, Inc. | SCHUSTER DISPOSABLE BALLOON PROBE | 1994-04-01 | 388 |
Recalls for FAP devices
6 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-04-08.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 2 |
Frequently asked questions
What is FDA product code FAP?
FAP is the FDA product code for cystometric gas (carbon-dioxide) on hydraulic device. It is a Class II device, regulated under 21 CFR 876.1620 and reviewed by the Gastroenterology and Urology panel.
What device class is FAP?
Class II, regulation 21 CFR 876.1620. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FAP?
Across 85 cleared submissions the average was 116 days from receipt to decision (median 78).
Which companies have the most FAP clearances?
Life-Tech Intl., Inc. (14); Browne Medical Systems, Inc. (7); Browne Corp. (7); Dantec Medical, Inc. (6); Warne Surgical Products, Ltd. (4).
Have FAP devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2021-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code FAP
- Run a recall and safety report across every FAP manufacturer
- Watch product code FAP 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.
All Gastroenterology and Urology product codes · FDA product code lookup