Jomed, Inc.: FDA clearances and approvals
Jomed, Inc. has 6 FDA 510(k) clearances (first 2001, latest 2003), across 4 product codes in 1 review panel. Median 510(k) review time: 39 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| OBJ | Catheter, Ultrasound, Intravascular | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Jomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031346 | JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 | OBJ | 2003-06-23 | 55 |
| K031148 | IN-VISION IMAGING SYSTEM | DXK | 2003-05-28 | 48 |
| K031277 | JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 | DQX | 2003-05-14 | 22 |
| K022762 | JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 | DQX | 2002-12-16 | 118 |
| K021219 | SMARTWIRE/SMARTMAP PRESSURE SYSTEM | DQX | 2002-05-17 | 30 |
| K003938 | TRAK BACK II | DQO | 2001-01-18 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Jomed, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Jomed, Inc. have?
Jomed, Inc. has 6 FDA 510(k) clearances (first 2001, latest 2003), across 4 product codes in 1 review panel.
How long does FDA take to clear Jomed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Jomed, Inc.'s cleared 510(k)s is 39 days.
What devices does Jomed, Inc. make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 3); DQO (Catheter, Intravascular, Diagnostic, 1); DXK (Echocardiograph, 1).
Has Jomed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jomed, Inc. Related entities may recall under other names.
Next steps
- See all 6 Jomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Jomed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.