# K952327: Smartsat Pulse Oximetry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Dynamics Corp.
- Decided: Aug 25, 1995 after 99 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 1 cites it directly.
0 of 24 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
- K971273: Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EF (1997), 22 descendants of its own
- K992340: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-PE (1999), 21 descendants of its own
- K062144: Escort M8 Vital Signs Patient Monitor, Model 3810 (2006), 11 descendants of its own
- K090556: Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software (2009), 10 descendants of its own
- K040178: Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device (2004), 5 descendants of its own

Source page: https://510kreport.com/device/K952327
Methodology: https://510kreport.com/methodology