Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Product & Educational Services — 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) |
|---|---|---|---|---|---|
| K941527 | MODEL 2300 GENERAL PURPOSE SUCTION PUMP | Product & Educational Services | 1994-05-18 | 49 | 0 |
| K941525 | MODEL 2200 THORACIC SUCTION PUMP | Product & Educational Services | 1994-05-18 | 49 | 0 |
| K941526 | MODEL 2000 MILD INTERMITTENT SUCTION PUMP | Product & Educational Services | 1994-05-18 | 49 | 0 |
| K941524 | MODEL 2100 MILD INTERMITTENT SUCTION PUMP | Product & Educational Services | 1994-05-17 | 48 | 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