# K970547: Isolyser SDS Sharps Container

- Pathway: 510(k) (Traditional)
- Applicant: Thantex Specialties, Inc.
- Decided: Jul 18, 1997 after 156 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 K943626 (1995). 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)
- K943626: Isolyser Sharps Management System SMS, Thantex Specialties, Inc. (1995) Summary page 1.

## Indications for use
The Isolyser SDS is a sharps container intended for use in non-clinical settings for the disposal of contaminated sharps.

Source page: https://510kreport.com/device/K970547
Methodology: https://510kreport.com/methodology