Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gambro-Hospal, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902588 | BSM/21&22 SC BLOOD SAFE MOD & V.P.M. VEN PRESS MOD | Gambro-Hospal, Inc. | 1991-03-07 | 268 | 0 |
| K896068 | TIPSTOP(TM) | Gambro-Hospal, Inc. | 1990-09-10 | 326 | 0 |
| K901368 | HEMOSPAL KITS A1, A2D, AO, & A1D | Gambro-Hospal, Inc. | 1990-08-02 | 132 | 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