# K943626: Isolyser Sharps Management System SMS

- Pathway: 510(k) (Traditional)
- Applicant: Thantex Specialties, Inc.
- Decided: Jun 16, 1995 after 325 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K090156: Isolyser Sharps Room System, Model 800; Isolyser Sharps Management System, Models 2400, 4000, 10000 (2009), 0 descendants of its own
- K090157: Isolyser Home Sharps Management (HSM), Model 800M; Isoly Sharps Management System (SMS), Models 2400M, 4000M, 10000M, 5. (2009), 0 descendants of its own
- K970547: Isolyser SDS Sharps Container (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K943626
Methodology: https://510kreport.com/methodology