510(k) · Cleared

Recalled · 2010

Spot Check Pulse Oximeter,512/513

K032949510(k) TraditionalCleared Aug 23, 2004336-day reviewClass II21 CFR 870.2700Recalls 2

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

Respironics Novametrix, Inc. · DQA Oximeter

Cleared on Aug 23, 2004 as substantially equivalent to K924626 (Novametrix Medical Systems, Inc., 1993) after a 336-day review. Its family tree reaches back 1 generation to 1993. It has been recalled 2 times.

Decided: Aug 23, 2004
Review: 336 days
Class: Class II
Product code: DQA
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K924626 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK924626 Novametrix Model 510Novametrix Medical Systems, Inc. · 1993
This deviceK032949 Spot Check Pulse Oximeter,512/513Respironics Novametrix, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924626	Novametrix Model 510	Novametrix Medical Systems, Inc.	1993	—
0 (this device)	K032949	Spot Check Pulse Oximeter,512/513	Respironics Novametrix, Inc.	2004	—

FIG. 1 — Lineage of K032949, 1993–2004Source: 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
*	K924626	Novametrix Model 510 Summary page 1 …ished accuracy specifications with the Model 510. The predicate device is as follows: 1. Model 510 Pulse Oximeter, Novametrix Medical Systems, Inc., K924626 e. Device Description The Model 512/53 Pulse Oximeters are designed for non-invasive measurement of the…	Novametrix Medical Systems, Inc.	1993	—

Also cleared against K924626: 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 27, 2010	Not classified	Z-0550-2011	Equipment maintenance	Unit may overestimate Sp02 levels in a high humidity environment.
Sep 27, 2010	Not classified	Z-0551-2011	Equipment maintenance	Unit may overestimate Sp02 levels in a high humidity environment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K924626.

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 Model 512 Handheld Pulse Oximeter is intended to provide non-invasive spot checking of

functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients in

hospital, hospital-type facilities and intra-hospital transport.

The Model 513 Handheld Pulse Oximeter is intended to provide continuous, non-invasive

monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and

adult patients in hospital, hospital-type facilities and intra-hospital transport.

The monitor and its sensors are intended to be used by trained operators when pulse oximetry

monitoring is required in the judgment of a licensed medical practitioner

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032949 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032949: Spot Check Pulse Oximeter,512/513.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032949

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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