510(k) · Cleared

Cleared

Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable Sensor

K132696510(k) SpecialCleared Sep 27, 201329-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 Sep 27, 2013 as substantially equivalent to K093881 (GE Healthcare Finland Oy, 2010) after a 29-day review. Its family tree reaches back 5 generations to 2001. 3 of the 12 devices in its family, counting itself, have a Class I recall.

Decided: Sep 27, 2013
Review: 29 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K010463 (2001). 11 ancestors in all, the oldest K962127 (1996). No later device cites it as a predicate yet. 3 of the 12 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 5 generations backK010463 Datex-Ohmeda Oxygen Saturation Module, M-Osat and AccessoiresDatex-Ohmeda, Inc. · 2001 · Recalled
4 generations backK011670 Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with…Datex-Ohmeda · 2001 · Recalled
3 generations backK021955 Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900…Datex-Ohmeda, Inc. · 2002 · Recalled (Class I)
2 generations backK040831 Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · Recalled (Class I)
1 generation backK093881 Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal…GE Healthcare Finland Oy · 2010 · Recalled (Class I)
This deviceK132696 Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorGE Healthcare Finland Oy · 2013

Class I recalls in this family

K093881 Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear…direct predicate · 2010
K040831 Datex-Ohmeda Trusat Pulse Oximeter and…2 generations back · 2004
K021955 Trutrak Plus Enhancements to the Datex-Ohmeda…2 generations back · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K010463	Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires	Datex-Ohmeda, Inc.	2001	1
−4	K011670	Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with…	Datex-Ohmeda	2001	1
−3	K021955	Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series…	Datex-Ohmeda, Inc.	2002	Class I
−2	K040831	Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500	Datex-Ohmeda, Inc.	2004	Class I
−1	K093881	Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap…	GE Healthcare Finland Oy	2010	Class I
0 (this device)	K132696	Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable Sensor	GE Healthcare Finland Oy	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0
1999	1	0
2004	1	0
2005	1	0
2006	1	0

FIG. 1 — Lineage of K132696, 2001–2013Source: 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.

3 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

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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
*	K093881	Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap Sensor Summary page 2 …Page 1of 7 Predicate Device(s) TruSignal SpO2 Alifit Sensortcleared in K093881 TruSignal® Sensors (807.92(a)(3): and Interconnect Cables Device Description The TruSignal SpO2 Adult…	GE Healthcare Finland Oy	2010	Class I

Also cleared against K093881: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

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 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & AccessoriesDatex-Ohmeda, Inc. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
6 of the 11 ancestors have a recall of any class; 3 have a Class I recall.
1 other device also cites its predicate K093881.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?

TS-AAW-10 and TS-AAW-25

The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: > 20 kg (>44 pounds)

TS-PAW-10 and TS-PAW-25

The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 3-20 kg (6.6-44 pounds)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132696 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132696: Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132696

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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