510(k) · Cleared

Cleared

Flexi-Stat SP02 Ear Sensor

K042675510(k) TraditionalCleared Dec 6, 200468-day reviewClass II21 CFR 870.2710

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

Elekon Industries U.S.A., Inc. · DPZ Oximeter, Ear

Cleared on Dec 6, 2004 as substantially equivalent to K944760 (Nellcor, Inc., 1994) after a 68-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Dec 6, 2004
Review: 68 days
Class: Class II
Product code: DPZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K944760 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK944760 Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc. · 1994
This deviceK042675 Flexi-Stat SP02 Ear SensorElekon Industries U.S.A., Inc. · 2004
Descendant · cites it directly · 0 of its ownK061191 Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric…Measurement Specialties, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K061191Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use…Measurement Specialties, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944760	Dura-Y Oxygen Transducer, Ear Clip	Nellcor, Inc.	1994	—
0 (this device)	K042675	Flexi-Stat SP02 Ear Sensor	Elekon Industries U.S.A., Inc.	2004	—
+1	K061191	Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors…	Measurement Specialties, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K042675, 1994–2006Source: 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 DPZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K944760	Dura-Y Oxygen Transducer, Ear Clip Summary page 1 …) Trade Name(s): Flexi-Stat SpO2 Ear Sensor Predicate Device: Elekon Flexi-StatTM ear sensor is substantially equivalent to the Neilcor Dura-Y ear sensor marketed under K944760. Description: The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical co…	Nellcor, Inc.	1994	—

Also cleared against K944760: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061191	Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use…	Measurement Specialties, Inc.	2006	0

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?

Its one ancestor has no recall.
Of its descendants, K061191 (Measurement Specialties, Inc., 2006) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K944760.

How does its category compare?

All DPZ devices

DPZ Oximeter, Ear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPZ

FDA has decided no DPZ device since 2007.

Median 510(k) review, days · DPZ

Too few DPZ 510(k)s in any year since 2007 to give a median.

Recalls per year · DPZ

1in 2011

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DPZ

1in 2025

2007high 43 (2014) · low 0 (2007)2025

MAUDE reports naming product code DPZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	1
2010	—	1	1
2011	—	1	13
2012	—	0	4
2013	—	0	22
2014	—	0	43
2015	—	0	6
2016	—	0	5
2017	—	0	4
2018	—	0	4
2019	—	0	2
2020	—	0	0
2021	—	0	1
2022	—	0	2
2023	—	0	0
2024	—	0	1
2025	—	0	1
2026	—	0	—

What is it indicated for?

Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042675 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042675: Flexi-Stat SP02 Ear Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042675

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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