Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Healthcare Service and Supply · 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) |
|---|---|---|---|---|---|
| K000303 | HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE P | Healthcare Service and Supply | 2000-05-16 | 105 | 0 |
| K974318 | HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE P | Healthcare Service and Supply | 1998-02-13 | 88 | 0 |
| K964188 | HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTA | Healthcare Service and Supply | 1997-05-06 | 197 | 0 |
| K955853 | HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM | Healthcare Service and Supply | 1996-06-25 | 187 | 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