Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BTX — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
24 daysmedian FDA review time
70 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935098 | BABY BOARD | Sentry Medical Products, Inc. | 1994-02-15 | 113 | 0 |
| K900175 | 4/1 ARMBOARD | Infection Control Products, Inc. | 1990-01-24 | 12 | 0 |
| K884838 | ALLEN PRONE ARMBOARD | Edgewater Medical Systems, Inc. | 1988-12-15 | 24 | 0 |
| K882524 | UNIVERSALLY ADJUSTABLE ARMBOARD | Karlin Technology, Inc. | 1988-07-08 | 21 | 0 |
| K881292 | ALLEN LATERAL ARMBOARD | Edgewater Medical Systems, Inc. | 1988-04-07 | 10 | 0 |
| K864670 | BOARD, ARM (WITH COVER) | Anago, Inc. | 1987-01-12 | 41 | 0 |
| K833664 | ARMBOARD AND THE BOARD | Rick Robbin & Frederick Auerbach | 1983-12-27 | 70 | 0 |
| K830018 | SAFE-T ARM BOARD | Harvey A. Turner, M.D. | 1983-01-26 | 23 | 0 |
| K823412 | ARM BOARD W/I.V COVERING | Sage Products, Inc. | 1982-12-15 | 30 | 0 |
| K811419 | SPRIO-LOOP | Datamed, Inc. | 1981-06-12 | 24 | 0 |
| K792147 | ARM SHIELD FOR ANESTHESIA | Medical Innovations Corp. | 1979-12-06 | 45 | 0 |
| K781233 | IV ARMBOARDS | Fibre Formations, Inc. | 1978-08-14 | 26 | 0 |
| K770391 | COVER, ARMBOARD, DISPOSABLE | Precept, Inc. | 1977-03-07 | 7 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda