JMS North America Corp.
Hayward, CA, US
JMS NORTH AMERICA CORP. appears in FDA device records in Hayward, CA. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for JMS North America Corp. between 2003 and 2025. The busiest year on record is 2004, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 1 |
| 2007 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 3 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2018 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251877 | JMS CAVEO A.V. Fistula Needle Set | FIE | Substantially Equivalent | |
| K172499 | NEOSHIELD | ONB | Substantially Equivalent | |
| K151017 | JMS Harmony A.V. Fistula Needle Set | FIE | Substantially Equivalent | |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | FIE | Substantially Equivalent | |
| K132321 | JMS SYRINGE | FMF | Substantially Equivalent | |
| K121488 | JMS SAFE WING CATH (SWC) | FOZ | Substantially Equivalent | |
| K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | FIE | Substantially Equivalent | |
| K111948 | WINGEATER V2 | FIE | Substantially Equivalent | |
| K110157 | SYSLOC MINI V3 | FIE | Substantially Equivalent | |
| K093637 | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 | FIE | Substantially Equivalent | |
| K082882 | A.V. FISTULA BLUNT NEEDLE SET | FIE | Substantially Equivalent | |
| K070234 | JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS | MPB | Substantially Equivalent | |
| K070143 | JMS PLANECTA STOPCOCK | FMG | Substantially Equivalent | |
| K051814 | JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET | FIE | Substantially Equivalent | |
| K032975 | JMS BLOOD TUBING SETS | FJK | Substantially Equivalent | |
| K032977 | JMS BYPASS TUBE | DWF | Substantially Equivalent | |
| K040247 | PLUME SAFETY AVF NEEDLE | FIE | Substantially Equivalent | |
| K030479 | JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET | FOZ | Substantially Equivalent | |
| K023668 | JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2954317 | 1000237783 | JMS NORTH AMERICA CORP. | 22320 FOOTHILL BLVD, HAYWARD, CA 94541 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- MPBCatheter, Hemodialysis, Non-Implanted
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- FIENeedle, Fistula
- FPASet, Administration, Intravascular
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FMGStopcock, I.V. Set
- FMFSyringe, Piston
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain