Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Enpath Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081394 | PTFE INTERLOCK PEELABLE INTRODUCERS | Enpath Medical, Inc. | 2008-09-15 | 119 | 0 |
| K072248 | VIAPEEL PEELABLE INTRODUCER | Enpath Medical, Inc. | 2007-11-09 | 88 | 0 |
| K071574 | STIFFER COAXIAL MICRO-INTRODUCER KIT | Enpath Medical, Inc. | 2007-07-05 | 27 | 2 |
| K063182 | ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 108 | Enpath Medical, Inc. | 2006-12-21 | 63 | 0 |
| K061119 | ENPATH MEDICAL STEERABLE SHEATH | Enpath Medical, Inc. | 2006-05-18 | 27 | 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