# K030629: Dolphin Medical 2150 Handheld Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Dolphin Medical, Inc.
- Decided: Sep 4, 2003 after 189 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: 5 generations back to K002036 (2001). 7 ancestors in all.
2 later devices descend 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)
- K024235: Dolphin Medical Stand-Alone Pulse Oximeter, Dolphin Medical, Inc. (2003). Cleared while this submission was under review
- K020075: Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter, Dolphin Medical, Inc. (2002)
- K953817: Aristo Medical Model 2101 Patient Monitor, Aristo Medical Products, Inc. (1995) Summary page 1.

## Most influential descendants
- K040380: Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420 (2004), 1 descendant of its own
- K242290: DormoTech NLab (2025), 0 descendants of its own

## Indications for use
The Dolphin Medical 2150 Handheld Pulse Oximeter is indicated for use for spot checking and/or continuous noninvasive monitoring of fractional oxygen saturation of arterial hemoglobin, pulse rate, and patient temperature. The 2150 is for use with adult pediatric and neonatal patients in hospitals and hospital type facilities.

Source page: https://510kreport.com/device/K030629
Methodology: https://510kreport.com/methodology