# K040380: Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420

- Pathway: 510(k) (Special)
- Applicant: Dolphin Medical, Inc.
- Decided: Aug 31, 2004 after 196 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: 6 generations back to K002036 (2001). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030629: Dolphin Medical 2150 Handheld Pulse Oximeter, Dolphin Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K242290: DormoTech NLab (2025), 0 descendants of its own

## Indications for use
The Dolphin ONE Model 420 oximetry sensor is indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate.

Source page: https://510kreport.com/device/K040380
Methodology: https://510kreport.com/methodology