# K892006: Healthdyne's Apnea/Heart Monitor, Model 900S

- Pathway: 510(k) (Traditional)
- Applicant: Healthdyne, Inc.
- Decided: May 23, 1989 after 56 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K011597: Smartmonitor 2, Model 4000 (2002), 2 descendants of its own
- K032403: Smartmonitor 2 Professional Series (PS) (2003), 1 descendant of its own
- K061256: Smartmonitor 2PS (2006), 0 descendants of its own
- K982550: Browser (Event Software) Model # 4500E (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K892006
Methodology: https://510kreport.com/methodology