# K911124: 503 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Criticare Systems, Inc.
- Decided: Jun 7, 1991 after 87 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K101012: V-Trust Handheld Pulse Oximeter Model: TD-8201 (2010), 2 descendants of its own
- K110893: Vtrust Finger Type Pulse Oximeter (2011), 1 descendant of its own
- K101259: V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002 (2010), 1 descendant of its own
- K172221: VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 (2018), 0 descendants of its own
- K151024: Finger Type Pulse Oximeter (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K911124
Methodology: https://510kreport.com/methodology