# K960641: RECAP-1

- Pathway: 510(k) (Traditional)
- Applicant: Medscience, Inc.
- Decided: May 17, 1996 after 93 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 K936235 (1994). 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)
- K936235: Needlesafe II & Needlegard II, Ingenious Technologies Corp. (1994). Our OCR of the scanned summary read K935235, FDA’s number for Endoscopy System for Facial Plastic Surgery (Smith & Nephew Richards, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Needlesafe II”.

## Indications for use
Recap-1 is used following OSHA guidelines to safely recap conventional needles prior to transport to an authorized sharps container in order to minimize the possibility of accidental needlesticks from occurring, after the injection procedure has been completed. The device would be used in all healthcare environments to protect healthcare workers and patients from needlesticks after the injection process has taken place.

Source page: https://510kreport.com/device/K960641
Methodology: https://510kreport.com/methodology