# K150093: Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Creative Industry Co., Ltd.
- Decided: Jun 3, 2015 after 138 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: 4 generations back to K001085 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063641: PC-60, Non-Invasivepulse Oximeter, Shenzhen Creative Industry Co., Ltd. (2007) Summary page 5.
- K120502: PC-60NW Fingertip Oximeter, Shenzhen Creative Industry Co., Ltd. (2012) Summary page 5.

## Indications for use
The Pulse OximeterV are intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display. These devices are used for spot-checking a patient's SpO2 and pulse rate in a home or clinical environment. They are intended to be used by adult and pediatric patients. These devices are recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.

Source page: https://510kreport.com/device/K150093
Methodology: https://510kreport.com/methodology