FDA product code BTX: Board, Arm (With Cover), Sterile
BTX is the FDA product code for board, arm (with cover), sterile. It is a Class I device, regulated under 21 CFR 878.3910 and reviewed by the General and Plastic Surgery panel. FDA has cleared 13 510(k) submissions under BTX, from 12 different applicants. The average 510(k) review took 34 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Board, Arm (With Cover), Sterile |
| Device class | Class I |
| Regulation | 21 CFR 878.3910 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BTX clearance
Top BTX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edgewater Medical Systems, Inc. | 2 | 1988-12-15 |
| Sentry Medical Products, Inc. | 1 | 1994-02-15 |
| Infection Control Products, Inc. | 1 | 1990-01-24 |
| Karlin Technology, Inc. | 1 | 1988-07-08 |
| Anago, Inc. | 1 | 1987-01-12 |
7 more applicants have BTX clearances. See the full list in Caduvo.
Most recent BTX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935098 | Sentry Medical Products, Inc. | BABY BOARD | 1994-02-15 | 113 |
| K900175 | Infection Control Products, Inc. | 4/1 ARMBOARD | 1990-01-24 | 12 |
| K884838 | Edgewater Medical Systems, Inc. | ALLEN PRONE ARMBOARD | 1988-12-15 | 24 |
| K882524 | Karlin Technology, Inc. | UNIVERSALLY ADJUSTABLE ARMBOARD | 1988-07-08 | 21 |
| K881292 | Edgewater Medical Systems, Inc. | ALLEN LATERAL ARMBOARD | 1988-04-07 | 10 |
Recalls for BTX devices
openFDA lists no recalls for product code BTX.
Frequently asked questions
What is FDA product code BTX?
BTX is the FDA product code for board, arm (with cover), sterile. It is a Class I device, regulated under 21 CFR 878.3910 and reviewed by the General and Plastic Surgery panel.
What device class is BTX?
Class I, regulation 21 CFR 878.3910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BTX?
Across 13 cleared submissions the average was 34 days from receipt to decision (median 24).
Which companies have the most BTX clearances?
Edgewater Medical Systems, Inc. (2); Sentry Medical Products, Inc. (1); Infection Control Products, Inc. (1); Karlin Technology, Inc. (1); Anago, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BTX
- Run a recall and safety report across every BTX manufacturer
- Watch product code BTX 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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