# K092727: H100B Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Dec 3, 2009 after 90 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: 14 generations back to K941811 (1994). 103 ancestors in all.
No later device cites it as a predicate yet.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072581: PM-60 Pulse Oximeter, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 1.

## Indications for use
The HIOOB Pulse oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities.

Source page: https://510kreport.com/device/K092727
Methodology: https://510kreport.com/methodology