Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sorenson Medical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
23 daysmedian FDA review time
115 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052221 | AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP | Sorenson Medical, Inc. | 2005-12-08 | 115 | 4 |
| K033425 | AMBIT INTERMITTENT AMBULATORY INFUSION PUMP | Sorenson Medical, Inc. | 2003-11-06 | 10 | 1 |
| K033325 | AMBIT CONTINUOUS AMBULATORY INFUSION PUMP | Sorenson Medical, Inc. | 2003-11-06 | 21 | 4 |
| K002434 | PALM PUMP | Sorenson Medical, Inc. | 2000-08-23 | 14 | 4 |
| K001287 | EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1 | Sorenson Medical, Inc. | 2000-06-09 | 46 | 0 |
| K991363 | 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KV | Sorenson Medical, Inc. | 1999-05-13 | 23 | 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