# K092641: Charmcare Tabletop Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Charmcare Co., Ltd.
- Decided: Oct 21, 2010 after 420 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 K962603 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 2.

## Indications for use
Charmcare Tabletop Pulse Oximeter is portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients via finger in hospitals, medical facilities, and subacute environments. Pediatric population in this 510(K) application is defined as 'infant' and 'child' which are ages from 1 month to 12 years according to the guidance 'Premarket Assessment of Pediatric Medical Devices' section IV. Charmcare Tabletop Pulse Oximeter is intended for spot-checking and / or continuous monitoring of patients, the sensor of device is reusable or disposable.

Source page: https://510kreport.com/device/K092641
Methodology: https://510kreport.com/methodology