BTX
13 FDA 510(k) clearances · Product code
24 daysmedian time to decision
70 days90th percentile
13clearances measured
FDA profile
- Official device name
- Board, Arm (With Cover), Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.3910
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1993: 1 · 1996: 1 · 1997: 1 · 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BABY BOARD (K935098) | Sentry Medical Products, Inc. | 1994-02-15 |
| 4/1 ARMBOARD (K900175) | Infection Control Products, Inc. | 1990-01-24 |
| ALLEN PRONE ARMBOARD (K884838) | Edgewater Medical Systems, Inc. | 1988-12-15 |
| UNIVERSALLY ADJUSTABLE ARMBOARD (K882524) | Karlin Technology, Inc. | 1988-07-08 |
| ALLEN LATERAL ARMBOARD (K881292) | Edgewater Medical Systems, Inc. | 1988-04-07 |
| BOARD, ARM (WITH COVER) (K864670) | Anago, Inc. | 1987-01-12 |
| ARMBOARD AND THE BOARD (K833664) | Rick Robbin & Frederick Auerbach | 1983-12-27 |
| SAFE-T ARM BOARD (K830018) | Harvey A. Turner, M.D. | 1983-01-26 |
| ARM BOARD W/I.V COVERING (K823412) | Sage Products, Inc. | 1982-12-15 |
| SPRIO-LOOP (K811419) | Datamed, Inc. | 1981-06-12 |
| ARM SHIELD FOR ANESTHESIA (K792147) | Medical Innovations Corp. | 1979-12-06 |
| IV ARMBOARDS (K781233) | Fibre Formations, Inc. | 1978-08-14 |
| COVER, ARMBOARD, DISPOSABLE (K770391) | Precept, Inc. | 1977-03-07 |
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Every clearance here is in the API, with alerts when new ones post.