# K980098: Vacutainer Brand Pronto Needles Holder

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: Feb 5, 1998 after 24 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- 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.
1 later device descends from it; 1 cites 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)
- K963748: Bio-Plexus Drop-IT Needle Holder, Bio-Plexus, Inc. (1997) Summary page 2.
- (no number) Autodrop®: named in the summary without a submission number

## Most influential descendants
- K032141: Secumax Blood Collection System (2004), 0 descendants of its own

## Indications for use
The VACUTAINER® Brand Pronto™ Needle Holder is a non-sterile, reusable device designed to attach and hold a VACUTAINER® Brand needle or VACUTAINER® Blood Collection Set during venipuncture.

Source page: https://510kreport.com/device/K980098
Methodology: https://510kreport.com/methodology