510(k) · Cleared

Cleared

Finger Type Pulse Oximeter

K151024510(k) TraditionalCleared Mar 2, 2016321-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

Taidoc Technology Corporation · DQA Oximeter

Cleared on Mar 2, 2016 as substantially equivalent to K110893 (Taidoc Technology Corporation, 2011) after a 321-day review. Its family tree reaches back 3 generations to 1991.

Decided: Mar 2, 2016
Review: 321 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K911124 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK911124 503 Pulse OximeterCriticare Systems, Inc. · 1991
2 generations backK101012 V-Trust Handheld Pulse Oximeter Model: TD-8201Taidoc Technology Corporation · 2010
1 generation backK110893 Vtrust Finger Type Pulse OximeterTaidoc Technology Corporation · 2011
This deviceK151024 Finger Type Pulse OximeterTaidoc Technology Corporation · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K911124	503 Pulse Oximeter	Criticare Systems, Inc.	1991	—
−2	K101012	V-Trust Handheld Pulse Oximeter Model: TD-8201	Taidoc Technology Corporation	2010	—
−1	K110893	Vtrust Finger Type Pulse Oximeter	Taidoc Technology Corporation	2011	—
0 (this device)	K151024	Finger Type Pulse Oximeter	Taidoc Technology Corporation	2016	—

FIG. 1 — Lineage of K151024, 1991–2016Source: 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? (1)

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
*	K110893	Vtrust Finger Type Pulse Oximeter Summary page 4 …Citation: 21 CFR §870.2700, Oximeter 3. Primary Predicate Device Proprietary Name: VTRUST Finger Type Pulse Oximeter 510(k) Number: k110893 4. Intended Use The Finger Type Pulse Oximeter is indicated for use in measuring oxygen saturation of arterial hemoglobin (SpO2)…	Taidoc Technology Corporation	2011	—

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?

The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

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 Finger Type Pulse Oximeter is indicated for use in measuring oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for patients during no-motion condition. The patients are limited to adults with weight above 40 kg.

This device is indicated for non-invasive spot checking.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151024 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151024: Finger Type Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151024

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026