Jms North America Corp.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Jms North America Corp.” (first 2003, latest 2025), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 291 |
| 2014 | 2 | 156 |
| 2015 | 1 | 27 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 287 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 58 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jms North America Corp. took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 178 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FIE | Needle, Fistula | 10 | 10 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 | 1 |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 1 | 1 |
Review panels
Most recent Jms North America Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251877 | JMS CAVEO A.V. Fistula Needle Set | FIE | 2025-08-15 | 58 |
| K172499 | NEOSHIELD | ONB | 2018-06-01 | 287 |
| K151017 | JMS Harmony A.V. Fistula Needle Set | FIE | 2015-05-13 | 27 |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | FIE | 2014-12-23 | 103 |
| K132321 | JMS SYRINGE | FMF | 2014-02-20 | 210 |
| K121488 | JMS SAFE WING CATH (SWC) | FOZ | 2013-03-05 | 291 |
| K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | FIE | 2011-10-27 | 91 |
| K111948 | WINGEATER V2 | FIE | 2011-10-24 | 108 |
| K110157 | SYSLOC MINI V3 | FIE | 2011-02-11 | 23 |
| K093637 | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 | FIE | 2010-02-09 | 77 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jms North America Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Jms North America Corp.?
FDA lists 19 510(k) clearances under the applicant name “Jms North America Corp.” (first 2003, latest 2025), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Jms North America Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jms North America Corp. is 108 days.
Which FDA product codes appear under Jms North America Corp.?
The most frequent FDA product codes under this applicant name are FIE (Needle, Fistula, 10); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1).
Next steps
- See all 19 Jms North America Corp. clearances with predicates and recalls
- Run predicate analysis for product code FIE, Jms North America Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.