# K895024: Punctur-Guard (TM) Blood Collection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Plexus, Inc.
- Decided: Sep 21, 1990 after 409 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
No predicates in its family tree.
8 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043258: Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02 (2004), 3 descendants of its own
- K070449: Lumiloc (TM) Safety Introducer Needle (2007), 1 descendant of its own
- K211072: Safety Trocar Cannula (2021), 0 descendants of its own
- K180725: Aspire Introducer Needle (2018), 0 descendants of its own
- K020985: Modified TFX Medical Safety Needle with Introducer (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K895024
Methodology: https://510kreport.com/methodology