# K063641: PC-60, Non-Invasivepulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Creative Industry Co., Ltd.
- Decided: Jul 13, 2007 after 218 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: 2 generations back to K001085 (2000). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051107: Onyx II Finger Pulse Oximeter, Model 9550, Nonin Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K120502: PC-60NW Fingertip Oximeter (2012), 1 descendant of its own
- 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 (2015), 0 descendants of its own

## Indications for use
The PC-60 Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries, it is small in size, convenient to use, and easy to carry. This device is applicable for spot-checking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device is recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.

Source page: https://510kreport.com/device/K063641
Methodology: https://510kreport.com/methodology