510(k) · Cleared

Recalled · Class I · 2023

Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & Accessories

K021955510(k) SpecialCleared Oct 8, 2002116-day reviewClass II21 CFR 870.2700Recalls 2 (2 Class I)

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

Cleared on Oct 8, 2002 as substantially equivalent to K962127 (Ohmeda Medical, 1996) and 2 other predicates after a 116-day review. Its family tree reaches back 2 generations to 2001. 4 of the 33 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.

Decided: Oct 8, 2002
Review: 116 days
Class: Class II
Product code: DQA
Recalls: 2 (2 Class I)
Predicates: 3

Its longest line of descent runs back 2 generations to K010463 (2001). 4 ancestors in all, the oldest K962127 (1996). 28 later devices descend from it, 2 citing it directly. 4 of the 33 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK010463 Datex-Ohmeda Oxygen Saturation Module, M-Osat and AccessoiresDatex-Ohmeda, Inc. · 2001 · Recalled
1 generation backK011670 Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with…Datex-Ohmeda · 2001 · Recalled
This deviceK021955 Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900…Datex-Ohmeda, Inc. · 2002
Descendant · cites it directly · 27 of its ownK040831 Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · Recalled (Class I)
Descendant · 2 generations on · 20 of its ownK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
Descendant · 3 generations on · 11 of its ownK102426 Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010
Descendant · 3 generations on · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
Descendant · 4 generations on · 8 of its ownK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2004high 3 (2013) · low 0 (2006)2026

Class I recalls in this family

K093881 Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear…cites it directly · 2010
K040831 Datex-Ohmeda Trusat Pulse Oximeter and…cites it directly · 2004
K133576 Monitor B405 generations on · 2014

Most influential descendants

Showing 5 of 28 · See all

K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · cites it directly27descendants
K073203Carescape V100Ge Medical Systems Information Technologies · 2007 · 2 generations on20descendants
K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010 · 3 generations on11descendants
K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · 3 generations on10descendants
K130584Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · 4 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010463	Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires	Datex-Ohmeda, Inc.	2001	1
−1	K011670	Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with…	Datex-Ohmeda	2001	1
0 (this device)	K021955	Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series…	Datex-Ohmeda, Inc.	2002	—
+1	K040831	Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500	Datex-Ohmeda, Inc.	2004	Class I
+2	K073203	Carescape V100	Ge Medical Systems Information Technologies	2007	—
+3	K102426	Carescape Model V100 Vital Signs Monitor	Ge Medical Systems Information Technologies	2010	—
+3	K120598	Procare Monitor B40	Ge Medical Systems China Co., Ltd.	2012	2
+4	K130584	Monitor B40	Ge Medical Systems China Co., Ltd.	2013	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	1
2005	2	0
2007	2	0
2010	2	1
2012	1	0
2013	3	0
2014	2	1
2015	3	0
2016	1	0
2017	3	0
2018	1	0
2019	1	0
2020	2	0
2022	1	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K021955, 2001–2025Source: 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.

4 devices in this family have a Class I recall. 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K962127	Ohmeda 3800 Pulse Oximeter	Ohmeda Medical	1996	—
*	K983684	Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters Summary page 1 …equivalent to the FDA 5 10(k) cleared and currently marketed Ohmeda 3800 Pulse Oximeter (K962 I27), the Datex-Ohmeda 3900/3900P Pulse Oximeters (K983684), and the Datex- Ohmeda M-OSAT Pulse Oximeters and Accessories (KO1 1670) The Datex-Ohm…	Datex-Ohmeda, Inc.	1998	—
*	K011670	Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with Trutrak+Motion…	Datex-Ohmeda	2001	1

Also cleared against K962127: 6 other devices →

What descends from it? (28)

See all 28

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040831	Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 Class I	Datex-Ohmeda, Inc.	2004	27
K093881	Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap Sensor Class I	GE Healthcare Finland Oy	2010	2

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 19, 2023	Class I	Z-2034-2023	Device Design	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
May 19, 2023	Class I	Z-2033-2023	Device Design	There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 13 Class I recalls
K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 1.3 years on median.
2 of the 4 ancestors have a recall of any class.
Of its descendants, K040831 (Datex-Ohmeda, Inc., 2004) has gone furthest, with 27 descendants of its own.
6 other devices also cite its predicate K962127.

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 Datex-Ohmeda 3800 Series and 3900 Series Oximeters with TruTrak Plus are indicated for spot-checking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion. These devices are intended for use with adult, pediatric and neonatal patients in both hospital and non-hospital environments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021955 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021955: Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021955

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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