510(k) · Cleared

Cleared

Spacelabs Medical Disposable SP02 Sensor

K981655510(k) TraditionalCleared Dec 3, 1999571-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 Dec 3, 1999 as substantially equivalent to K915699 (Nellcor, Inc., 1993) and 2 other predicates after a 571-day review. Its family tree reaches back 1 generation to 1989.

Decided: Dec 3, 1999
Review: 571 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K893643 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK893643 Novametrix MDLS 500A, 505A, 515A, & 7000A OximeterNovametrix Medical Systems, Inc. · 1989 · Recalled
This deviceK981655 Spacelabs Medical Disposable SP02 SensorSpacelabs Medical, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K893643	Novametrix MDLS 500A, 505A, 515A, & 7000A Oximeter	Novametrix Medical Systems, Inc.	1989	6
0 (this device)	K981655	Spacelabs Medical Disposable SP02 Sensor	Spacelabs Medical, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1996	1	0

FIG. 1 — Lineage of K981655, 1989–1999Source: 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? (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
*	K915699	Nellcor Portable Pulse Oximeter Model N-20 Summary page 1 …evices with identical intended uses. Specifically, these sensors are substantially equivalent to disposable sensors marketed by Nelicor Puritan Bennett (510(k) reference K915699), Novamterix (K893643) and Ohmeda (K962127) for monitoring As an accessory to a pulse oximeter monitoring module in a Spacelabs…	Nellcor, Inc.	1993	—
*	K893643	Novametrix MDLS 500A, 505A, 515A, & 7000A Oximeter Summary page 1 …intended uses. Specifically, these sensors are substantially equivalent to disposable sensors marketed by Nelicor Puritan Bennett (510(k) reference K915699), Novamterix (K893643) and Ohmeda (K962127) for monitoring As an accessory to a pulse oximeter monitoring module in a Spacelabs Medical Information Sy…	Novametrix Medical Systems, Inc.	1989	6
*	K962127	Ohmeda 3800 Pulse Oximeter Summary page 1 …ically, these sensors are substantially equivalent to disposable sensors marketed by Nelicor Puritan Bennett (510(k) reference K915699), Novamterix (K893643) and Ohmeda (K962127) for monitoring As an accessory to a pulse oximeter monitoring module in a Spacelabs Medical Information System (PCIS), a Spacel…	Ohmeda Medical	1996	—

Also cleared against K915699: 1 other device →

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?

1 of the 3 ancestors has a recall of any class.
1 other device also cites its predicate K915699.

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?

An accessory to an SpO2 monitoring system for use in noninvasive, continuous monitoring of oxygen saturation for the detection of dessturation due to abnormal puimonary/circulatory function in adult, pediatric or infant population by the standard photoelectric pulse of oximetric technique.

Sensors are available for common monitoring sites, including the fingertip and foot.

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/K981655 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981655: Spacelabs Medical Disposable SP02 Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981655

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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