# K101012: V-Trust Handheld Pulse Oximeter Model: TD-8201

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Dec 15, 2010 after 247 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
Longest line of descent: 1 generation back to K911124 (1991). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911124: 503 Pulse Oximeter, Criticare Systems, Inc. (1991) Summary page 1.

## Most influential descendants
- K110893: Vtrust Finger Type Pulse Oximeter (2011), 1 descendant of its own
- K151024: Finger Type Pulse Oximeter (2016), 0 descendants of its own

## Indications for use
The VITRUST Handheld Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (5p02) and pulse rate for adults. This device with reusable SP02 sensor accessories is indicated for non-invasive spot checking or continuous monitoring.

Source page: https://510kreport.com/device/K101012
Methodology: https://510kreport.com/methodology