Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgi-Med, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
85 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881705 | MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM | Surgi-Med, Inc. | 1988-07-13 | 85 | 0 |
| K873047 | KEANE MOBILITY BED | Surgi-Med, Inc. | 1987-10-15 | 72 | 0 |
| K872923 | PARAGON 9000 TILT AND TURN BED | Surgi-Med, Inc. | 1987-10-14 | 79 | 0 |
| K872924 | PARAGON 8500 CARDIO-PULMONARY BED | Surgi-Med, Inc. | 1987-10-09 | 74 | 0 |
| K872925 | MEGABED 1000 | Surgi-Med, Inc. | 1987-09-15 | 50 | 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