# K011786: Vacuette Safety Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Vacuette North America, Inc.
- Decided: Jul 12, 2001 after 34 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912563 (1991). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912563: Angel Wing Safety Blood Collection and Infusion SE, Mbo Laboratories, Inc. (1991) Summary page 1.
- (no number) Monoject® Angel Wing Blood Collection Set: named in the summary without a submission number

## Most influential descendants
- K080235: Safety Infusion Set (2008), 7 descendants of its own
- K121908: Safety Infusion Set (2012), 6 descendants of its own
- K173757: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set (2018), 2 descendants of its own
- K170276: Safety Blood Collection Device for Single Use (2017), 2 descendants of its own
- K214075: Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) (2022), 1 descendant of its own

## Recalls of this device
- Feb 1, 2013 · Class II · Z-0835-2013: The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
- Mar 10, 2003 · Not classified · Z-0797-03: The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.

## Indications for use
The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The VACUETTE® Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

Source page: https://510kreport.com/device/K011786
Methodology: https://510kreport.com/methodology