# K962149: Safety Cradle

- Pathway: 510(k) (Traditional)
- Applicant: Specialized Health Products, Inc.
- Decided: Oct 11, 1996 after 129 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 K901321 (1990). 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)
- K901321: Sharp-Safe, Biodegradeable,Disp., Needle Disp. Box, Sharp Safe, Inc. (1990) Summary page 1.

## Indications for use
For storage and disposal of used sharps devices.

Source page: https://510kreport.com/device/K962149
Methodology: https://510kreport.com/methodology