# K963678: Caretone II

- Pathway: 510(k) (Traditional)
- Applicant: American Telecare, Inc.
- Decided: Feb 24, 1997 after 164 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.
46 later devices descend from it; 3 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CareTone Telephonic Stethoscope: named in the summary without a submission number

## Most influential descendants
- K973873: Digital Personal Telemedicine Module, Digital PTM 1 (1997), 36 descendants of its own
- K034046: RNK Telephonic Stethoscope, Model TR-1 (2004), 32 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

## Indications for use
The intended use of American Telecare, Inc.’s CareTone II is to conduct a stethoscope examination of a patient by a nurse or physician at another location using a communications line.

Source page: https://510kreport.com/device/K963678
Methodology: https://510kreport.com/methodology