# K963748: Bio-Plexus Drop-IT Needle Holder

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Plexus, Inc.
- Decided: Jun 6, 1997 after 262 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vacutainer® Brand Needle Holder #4893: named in the summary without a submission number
- (no number) Sage Products AutoDrop® Needle Holder #1510: named in the summary without a submission number

## Most influential descendants
- K980098: Vacutainer Brand Pronto Needles Holder (1998), 1 descendant of its own
- K032141: Secumax Blood Collection System (2004), 0 descendants of its own
- K992091: Punctur-Guard Revolution Holder, Model 4750 (1999), 0 descendants of its own

## Indications for use
The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder which is recommended for use with standard blood collection needles including the PUNCTUR-GUARD® Blood Collection Needle as well as PUNCTUR-GUARD® Winged Sets for Blood Collection. It also mates with the Bio-Plexus Needle Disposal Container for easy needle diqusal. This is a non-sterile reusable device recommended for a maximum of 100 uses.

Source page: https://510kreport.com/device/K963748
Methodology: https://510kreport.com/methodology