Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zevex, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
294 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution | Zevex, Inc. | 2024-10-03 | 29 | 0 |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution | Zevex, Inc. | 2024-05-17 | 249 | 0 |
| K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enter | Zevex, Inc. | 2015-01-08 | 121 | 0 |
| K131154 | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE I | Zevex, Inc. | 2014-02-12 | 294 | 0 |
| K012147 | DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND | Zevex, Inc. | 2001-11-02 | 115 | 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