# K910770: 504US Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Criticare Systems, Inc.
- Decided: May 14, 1991 after 81 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K043463: Envitec Reusable Multi-Site Y SPO2 Sensors (2005), 5 descendants of its own
- K060675: Envitec Reusable Softip Y SPO2 Sensors (2006), 4 descendants of its own
- K101690: Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable (2010), 3 descendants of its own
- K151329: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (2015), 1 descendant of its own
- K232516: Sentec Digital Monitoring System (SDMS) tCOM+ (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K910770
Methodology: https://510kreport.com/methodology