510(k) · Cleared

Recalled · Class II · 2024

Avoximeter

K922075510(k) TraditionalCleared Nov 4, 1992184-day reviewClass II21 CFR 870.2700Recalls 3

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

Cleared on Nov 4, 1992 after a 184-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 3 times.

Decided: Nov 4, 1992
Review: 184 days
Class: Class II
Product code: DQA
Recalls: 3
Predicates: 0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K922075Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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, 2024	Class II	Z-0279-2025	Process change control	Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care…
Feb 13, 2008	Not classified	Z-1237-2008	Process design	Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.
Feb 13, 2008	Not classified	Z-1238-2008	Process design	Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.

No ancestor or descendant has a Class I recall.

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	—

https://510kreport.com/device/K922075 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922075: Avoximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922075

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026