# K955748: Doyle Extractor

- Pathway: 510(k) (Traditional)
- Applicant: Safetech Intl., Inc.
- Decided: Mar 14, 1996 after 90 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 K760733 (1976). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810187: Auto Suture PSS Skin Stapling Instrument, United States Surgical, A Division of Tyco Healthc (1981) Summary page 2.
- K914130: Auto Suture Titanium Skin and Fascia Staples, United States Surgical, A Division of Tyco Healthc (1991) Summary page 2.
- K760733: Skin Staple Extractor, ETHICON, Inc. (1976) Summary page 2.

## Most influential descendants
- K973497: Huberloc (1998), 1 descendant of its own
- K021916: Harmac Huber Needle Safety Device, H2984001 (2002), 0 descendants of its own

## Indications for use
The Doyle Extractor is a needle extractor intended for use as an accessory to IV administration sets. Specifically, the Doyle Extractor is intended for use during the removal of right-angle needles from implanted IV ports.

Source page: https://510kreport.com/device/K955748
Methodology: https://510kreport.com/methodology