# K122687: Blood Culture Holder

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One North America, Inc.
- Decided: Jan 10, 2013 after 128 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K895367 (1989). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081229: Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T Wing, Smiths Medical Asd, Inc. (2008) Summary page 1.

## Most influential descendants
- K193074: Bevel Up Holder (2020), 1 descendant of its own
- K242320: BD Vacutainer® One Use Holder (2024), 0 descendants of its own
- K232881: Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder (2023), 0 descendants of its own

## Indications for use
The Blood Culture Holder is used to fill blood into blood culture bottles and tubes in routine venipuncture procedures. This device is to be used by property trained healthcare professionals only in accordance with these instructions. The SAFETY Blood Collection Set and/or Blood Collection Set + Blood Culture Holder are used in routine venipuncture procedures. The winged needle of the SAFETY Blood Collection Set is designed with a safety shield, which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick Injury. The Blood Culture Holder is used to fill blood into blood culture bottles and tubes.

Source page: https://510kreport.com/device/K122687
Methodology: https://510kreport.com/methodology