510(k) · Cleared

Cleared

Osi Medical Digital Dolphin 3000 Pulse Oximeter; Digital Dolphin Reusable Optical Sensor, Model 210'

K014218510(k) TraditionalCleared Nov 7, 2002321-day reviewClass II21 CFR 870.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Nov 7, 2002 as substantially equivalent to K002036 (Osi Medical, Inc., 2001) and 1 other predicate after a 321-day review. Its family tree reaches back 1 generation to 2000.

Decided: Nov 7, 2002
Review: 321 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K001995 (2000). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK001995 Spiroxcard Diagnostic Spirometer and Pulse OximeterQrs Diagnostic, LLC · 2000
This deviceK014218 Osi Medical Digital Dolphin 3000 Pulse Oximeter; Digital Dolphin…Dolphin Medical, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001995	Spiroxcard Diagnostic Spirometer and Pulse Oximeter	Qrs Diagnostic, LLC	2000	—
0 (this device)	K014218	Osi Medical Digital Dolphin 3000 Pulse Oximeter; Digital Dolphin Reusable…	Dolphin Medical, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K014218, 2000–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQA device

#1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K002036	Osi Medical Dolphin Stand-Alone Pulse Oximeter, Model 2100 and Digital Dolphin Optical… Summary page 1 …cessories is substantially equivalent to the following currently marketed device(s): Dolphin Medical Stand Alone Pulse Oximeter, Model No. 2100 and Accessories #K002036. QRS Diagnostic Spiroxcard Diagnostic Spirometer and Pulse Oximeter #KO01 995. The Voyager consists of a CF card, and a…	Osi Medical, Inc.	2001	—
*	K001995	Spiroxcard Diagnostic Spirometer and Pulse Oximeter	Qrs Diagnostic, LLC	2000	—

Also cleared against K002036: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
6 other devices also cite its predicate K002036.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	122	6	325
2008	22	97	5	312
2009	35	117	29	281
2010	29	127	4	185
2011	15	195	1	164
2012	14	120	0	322
2013	15	182	0	468
2014	11	175	2	1,124
2015	13	158	1	2,082
2016	14	246	0	1,775
2017	9	200	0	1,190
2018	18	260	32	694
2019	19	158	0	548
2020	15	126	0	426
2021	10	174	0	553
2022	20	265	0	478
2023	13	317	0	392
2024	14	285	3	545
2025	15	182	0	399
2026	8	187	0	—

What is it indicated for?

The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous

noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate

(measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K014218 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014218: Osi Medical Digital Dolphin 3000 Pulse Oximeter; Digital Dolphin Reusable Optical Sensor, Model 210'.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014218

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026