510(k) · Cleared

Cleared

Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)

K250931510(k) TraditionalCleared Aug 13, 2025138-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

Unimed Medical Supplies, Inc. · DQA Oximeter

Cleared on Aug 13, 2025 as substantially equivalent to K093881 (GE Healthcare Finland Oy, 2010) after a 138-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: Aug 13, 2025
Review: 138 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 deviceK250931 Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117)…Unimed Medical Supplies, Inc. · 2025

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)	K250931	Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed…	Unimed Medical Supplies, Inc.	2025	—

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 K250931, 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.

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 5 …Trade Name TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL K093881 SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR Add: B…	GE Healthcare Finland Oy	2010	Class I
†	K151063	Monitor B40	Ge Medical Systems China Co., Ltd.	2015	1

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 24 years and passes through 4 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. 2025, 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?

Unimed Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K250931 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250931: Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250931

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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