510(k) K991088 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE
| Applicant | Becton Dickinson Vacutainer Systems, Franklin Lake NJ, US |
| Decision | Substantially Equivalent, May 28, 1999 |
| Received | Apr 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2022 | ROi CPS LLC Regard Custom Procedure Kits containing BD Luer Lok Access Devices Terminated |
LRS | None listed |
| Jan 6, 2022 | Becton Dickinson & Company BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample co Open, Classified |
JKA | None listed |
| Dec 6, 2006 | Becton Dickinson & Company BD Vacutainer Luer-Lok Access Device
Holder with Pre-Attached Multiple Sample Adapter
Sterile, Do Not Reuse, Keep away from heat, Rx only
Ref # 364902
200 (4X50)
BD Franklin Lakes, NJ 07417 Terminated |
JKA | None listed |
| Sep 9, 2006 | Becton Dickinson & Company BD Vacutainer Luer Adapter; Catalog #367290 and #367300. Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.