# K992091: Punctur-Guard Revolution Holder, Model 4750

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Plexus, Inc.
- Decided: Sep 9, 1999 after 80 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963748 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963748: Bio-Plexus Drop-IT Needle Holder, Bio-Plexus, Inc. (1997) Summary page 1.

## Indications for use
The REVOLUTION Holder is used in blood drawing procedures. It is used with PUNCTUR-GUARD® Blood Collection Needles only, and is compatible with standard blood sample tubes as well as pediatric inserts. The REVOLUTION Holder should be used by health care workers experienced in phlebotomy. At the end of a blood draw, the holder dial is rotated clockwise 90°. This rotation activates the safety mechanism of the PUNCTUR-GUARD® needle, which reduces the probability of an accidental needle stick. The needle can be eliminated quickly by a push on the release button. The holder is re-usable for up to 100 draws, including 20 cleanings.

Source page: https://510kreport.com/device/K992091
Methodology: https://510kreport.com/methodology