# K963621: Stethos

- Pathway: 510(k) (Traditional)
- Applicant: Theratechnologies, Inc.
- Decided: Dec 4, 1996 after 89 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
52 later devices descend from it; 1 cites it directly.
0 of 53 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
- K991367: Meditron Stethoscope System (1999), 51 descendants of its own
- K072026: RNK Electronic Stethoscope (2007), 29 descendants of its own
- K102893: PCP/PC Stethoscope (2011), 26 descendants of its own
- K160401: Tyto Stethoscope (2016), 21 descendants of its own
- K181612: Tyto Stethoscope (OTC) (2018), 19 descendants of its own

Source page: https://510kreport.com/device/K963621
Methodology: https://510kreport.com/methodology