# K220458: UltraFlo-R Push Button Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Medical Technologies, Inc.
- Decided: Sep 29, 2023 after 589 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Ultraflo-R Push Button Blood Collection Set is a sterile, single-use, winged blood collection set intended for venipuncture to obtain blood specimens from patients. The device is connected to a syringe or evacuated blood collection tube for collection of the specimen. The Ultraflo-R Push Button Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for patient populations over 2500 grams with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. After completion of the blood draw or infusion, the recommended use of the device is to depress the button on the top of the device to activate needle retraction into the device prior to removal from the venipuncture site. This is a one-handed activation of the safety feature. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needle-stick injury. The device is not used for a diagnostic or treatment purpose.

Source page: https://510kreport.com/device/K220458
Methodology: https://510kreport.com/methodology