Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jomed, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
118 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031346 | JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 | Jomed, Inc. | 2003-06-23 | 55 | 0 |
| K031148 | IN-VISION IMAGING SYSTEM | Jomed, Inc. | 2003-05-28 | 48 | 0 |
| K031277 | JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,1413 | Jomed, Inc. | 2003-05-14 | 22 | 0 |
| K022762 | JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG14 | Jomed, Inc. | 2002-12-16 | 118 | 0 |
| K021219 | SMARTWIRE/SMARTMAP PRESSURE SYSTEM | Jomed, Inc. | 2002-05-17 | 30 | 0 |
| K003938 | TRAK BACK II | Jomed, Inc. | 2001-01-18 | 29 | 1 |
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