# K991088: Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: May 28, 1999 after 57 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931367 (1993). 2 ancestors in all.
14 later devices descend from it; 6 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931367: Vacutainer Brand Luer Adapter, Bd Becton Dickinson Vacutainer Systems Preanalytic (1993) Summary page 3.
- K983490: Terumo Venoject,Luer Adapter, Terumo Corp. (1998) Summary page 3.

## Most influential descendants
- K200027: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter (2020), 6 descendants of its own
- K222478: BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device (2023), 1 descendant of its own
- K190485: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (2019), 1 descendant of its own
- K160532: Greiner Holdex (2016), 1 descendant of its own
- K252899: Female Culture Device; Male Culture Device; Transfer Device; Access Device (2026), 0 descendants of its own

## Recalls of this device
- Feb 24, 2022 · Class III · Z-0837-2022: Recalled devices were packaged in convenience kits.
- Jan 6, 2022 · Class III · Z-0665-2022: May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations 
- Sep 8, 2006 · Not classified · Z-0253-2007: Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.
- Jun 21, 2006 · Not classified · Z-1462-06: Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.

## Indications for use
The VACUTAINER® Brand Luer Adapter is a sterile, non-invasive device used to connect venous access devices such as needles, blood collection sets, and infusion sets to blood collection tubes. They are also used in connection with non-needle devices for collection of blood from catheters. The VACUTAINER® Brand Luer Adapter is sold by itself and as a component of other VACUTAINER Brand devices.

Source page: https://510kreport.com/device/K991088
Methodology: https://510kreport.com/methodology