510(k) · Cleared

Cleared

V-Trust Handheld Pulse Oximeter Model: TD-8201

K101012510(k) TraditionalCleared Dec 15, 2010247-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 Dec 15, 2010 as substantially equivalent to K911124 (Criticare Systems, Inc., 1991) after a 247-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.

Decided: Dec 15, 2010
Review: 247 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K911124 (1991). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK911124 503 Pulse OximeterCriticare Systems, Inc. · 1991
This deviceK101012 V-Trust Handheld Pulse Oximeter Model: TD-8201Taidoc Technology Corporation · 2010
Descendant · cites it directly · 1 of its ownK110893 Vtrust Finger Type Pulse OximeterTaidoc Technology Corporation · 2011
Descendant · 2 generations on · 0 of its ownK151024 Finger Type Pulse OximeterTaidoc Technology Corporation · 2016

Most influential descendants

Showing 2 of 2 · See all

K110893Vtrust Finger Type Pulse OximeterTaidoc Technology Corporation · 2011 · cites it directly1descendant
K151024Finger Type Pulse OximeterTaidoc Technology Corporation · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2016	1	0

FIG. 1 — Lineage of K101012, 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
*	K911124	503 Pulse Oximeter Summary page 1 …ommon/Usual Name: Oximeter Submitter CRITICARE SYSTEMS, INC. 510 (k) Number K911124 4. Device Description Ii The V-TRUST Handheld Pulse Oximeter is a light weight, portable and non-invasive…	Criticare Systems, Inc.	1991	—

Also cleared against K911124: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K110893	Vtrust Finger Type Pulse Oximeter	Taidoc Technology Corporation	2011	1

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?

Its one ancestor has no recall.
Of its descendants, K110893 (Taidoc Technology Corporation, 2011) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K911124.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 VITRUST Handheld Pulse Oximeter is indicated for use in measuring and

displaying functional oxygen saturation of arterial hemoglobin (5p02) and pulse

rate for adults.

This device with reusable SP02 sensor accessories is indicated for non-invasive

spot checking or continuous monitoring.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101012 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101012: V-Trust Handheld Pulse Oximeter Model: TD-8201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101012

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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