Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alimed, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
57 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963527 | UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS | Alimed, Inc. | 1996-10-31 | 57 | 0 |
| K963528 | ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL | Alimed, Inc. | 1996-10-29 | 55 | 0 |
| K963526 | STRAP WEDGE | Alimed, Inc. | 1996-10-28 | 54 | 0 |
| K920487 | MINI VIBRATOR | Alimed, Inc. | 1992-02-18 | 19 | 0 |
| K840156 | PROTECTA COAT SPONGES | Alimed, Inc. | 1984-03-23 | 70 | 0 |
| K822650 | SUPER DONUT | Alimed, Inc. | 1982-09-30 | 28 | 0 |
| K822651 | TOTAL FINGER FLEXION SPLINT | Alimed, Inc. | 1982-09-17 | 15 | 0 |
| K820516 | ARTERIAL CANALIZATION DEVICE | Alimed, Inc. | 1982-04-15 | 49 | 0 |
| K820517 | CONSTRUCTA FOAM | Alimed, Inc. | 1982-03-10 | 13 | 0 |
| K801743 | PLASTAZOTE SHOE | Alimed, Inc. | 1980-08-07 | 10 | 0 |
| K791189 | ECHO CARDIOGRAM PAD | Alimed, Inc. | 1979-07-17 | 21 | 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