510(k) · Cleared

Cleared

Flexi-Stat Disposable Adhesive SPO2 Sensors

K041522510(k) TraditionalCleared Sep 14, 200499-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

Elekon Industries U.S.A., Inc. · DQA Oximeter

Cleared on Sep 14, 2004 as substantially equivalent to K991823 (Nellcor Puritan Bennett, Inc., 1999) and 3 other predicates after a 99-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.

Decided: Sep 14, 2004
Review: 99 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K962603 (1997). 8 ancestors in all, the oldest K955642 (1996). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
2 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
1 generation backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
This deviceK041522 Flexi-Stat Disposable Adhesive SPO2 SensorsElekon Industries U.S.A., Inc. · 2004
Descendant · cites it directly · 1 of its ownK042705 Disposable Non-Adhesive SPO2 SensorsElekon 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 2 of 2 · See all

K042705Disposable Non-Adhesive SPO2 SensorsElekon Industries U.S.A., Inc. · 2004 · cites it directly1descendant
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
−4	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−3	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−2	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
−1	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
0 (this device)	K041522	Flexi-Stat Disposable Adhesive SPO2 Sensors	Elekon Industries U.S.A., Inc.	2004	—
+1	K042705	Disposable Non-Adhesive SPO2 Sensors	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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1998	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0

FIG. 1 — Lineage of K041522, 1997–2006Source: 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 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? (5)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K86378	Nellcor, BCI, and Datex pulse oximeter sensors Number could not be read Summary page 1 …Stat SpO2 Sensors Predicate Device: Elekon Flexi-StatTM sensors are substantially equivalent to Nellcor, BCI, and Datex pulse oximeter sensors marketed under 510(k) ft K86378, K991823, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 5 10O(k) Ii K9…
*	K991823	N-395 Pulse Oximeter, Model N-395 Summary page 1 …2 Sensors Predicate Device: Elekon Flexi-StatTM sensors are substantially equivalent to Nellcor, BCI, and Datex pulse oximeter sensors marketed under 510(k) ft K86378, K991823, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 5 10O(k) Ii K992215.…	Nellcor Puritan Bennett, Inc.	1999	—
*	K962156	3304 Pulse Oximeter Summary page 1 …Predicate Device: Elekon Flexi-StatTM sensors are substantially equivalent to Nellcor, BCI, and Datex pulse oximeter sensors marketed under 510(k) ft K86378, K991823, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 5 10O(k) Ii K992215. Descripti…	Bci Intl., Inc.	1996	—
*	K983684	Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters Summary page 1 …Device: Elekon Flexi-StatTM sensors are substantially equivalent to Nellcor, BCI, and Datex pulse oximeter sensors marketed under 510(k) ft K86378, K991823, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 5 10O(k) Ii K992215. Description: The Flex…	Datex-Ohmeda, Inc.	1998	—
*	K992215	Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable… Summary page 1 …er sensors marketed under 510(k) ft K86378, K991823, K962156, and K983684. These sensors are also equivalent to Envitec's after-market sensors marketed under 5 10O(k) Ii K992215. Description: The Flexi-Stat(tm) SPO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical…	Envitec-Wismar GmbH	2000	—

Also cleared against K991823: 20 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042705	Disposable Non-Adhesive SPO2 Sensors	Elekon Industries U.S.A., Inc.	2004	1
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?

The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 11 months on median.
None of the 8 ancestors has a recall.
Of its descendants, K042705 (Elekon Industries U.S.A., Inc., 2004) has gone furthest, with 1 descendant of its own.
20 other devices also cite its predicate K991823.

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 Flexi-Stat SpO₂ Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients Weighing > 30 kg.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041522 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041522: Flexi-Stat Disposable Adhesive SPO2 Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041522

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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