Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gsi Development Co. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926456 | MICROAIR TURN-Q | Gsi Development Co. | 1993-03-24 | 90 | 0 |
| K914674 | MICROAIR 3500 | Gsi Development Co. | 1991-11-22 | 35 | 0 |
| K893708 | FLUIDIZED AIR BED | Gsi Development Co. | 1989-06-22 | 35 | 0 |
| K884529 | MICROAIR FLUIDIZED AIR BED | Gsi Development Co. | 1988-11-18 | 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