# K123987: Improve Blood Collection Set and Improsafe Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Medical Technologies, Inc.
- Decided: Aug 27, 2013 after 244 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K202188: Safety Blood Collection Sets for Single Use (2021), 0 descendants of its own
- K163093: Safety Blood Collection Set (2017), 0 descendants of its own

## Recalls of this device
- Sep 22, 2017 · Class II · Z-2549-2018: Leaks complaints.
- Sep 22, 2017 · Class II · Z-1217-2019: Complain due to the hub needle came out when the nurse draw the blood and removed the tube.
- Oct 19, 2016 · Class II · Z-2790-2018: Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.

## Indications for use
Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a non-patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter. The Improsafe Blood Collection Set is provided with an attached safety shield for covering the used needle prior to disposal. After withdrawal of the needle from the patient’s vein, the attached safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick. The Improve Blood Collection Set and Improsafe Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. For devices that include the male luer adapter: after removing the attached male luer adapter from the blood collection set, connect the female luer adapter to a syringe or other compatible/appropriate device.

Source page: https://510kreport.com/device/K123987
Methodology: https://510kreport.com/methodology