# K212724: BD Vacutainer UltraTouch Push Button Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Feb 4, 2022 after 161 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: 6 generations back to K970259 (1997). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153309: BD Vacutainer UltraTouch Push Button Blood Collection Set, Becton, Dickinson and Company (2016) Summary page 5.

## Most influential descendants
- K223854: Unistik® ShieldLock, Unistik VacuFlip (2023), 0 descendants of its own

## Indications for use
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens from patients, including those patients with difficult vein access who may have small, fragile, and/or non-palpable veins, into evacuated blood collection tubes and/or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe, if necessary. The device can be used for short-term, single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and is to remain under the direct supervision of a clinician. The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

Source page: https://510kreport.com/device/K212724
Methodology: https://510kreport.com/methodology