# K963830: Sharps Container Model# SC001

- Pathway: 510(k) (Traditional)
- Applicant: Image Medical, Inc.
- Decided: Feb 10, 1997 after 139 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 K943575 (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)
- K943575: B-D Guardian Nestable Sharps Collectors, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K843860: Oxyscreen, Erich Jaeger, Inc. (1984). Our OCR of the scanned summary read K843860, FDA’s number for Oxyscreen (Erich Jaeger, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sage Sharps Disposal System”. Kept off the family tree.

## Indications for use
This container is for use by Law Enforcement Agencies. Law Enforcement Officials who frequently encounter syringes and other sharps during searches of suspects, vehicles, property or location.

Source page: https://510kreport.com/device/K963830
Methodology: https://510kreport.com/methodology