510(k) · Cleared

Cleared

Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable Sensor, Multicompatible Envitec Ped

K992215510(k) TraditionalCleared Mar 29, 2000272-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 Mar 29, 2000 after a 272-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it.

Decided: Mar 29, 2000
Review: 272 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 0

14 later devices descend from it, 4 citing it directly.

This deviceK992215 Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec…Envitec-Wismar GmbH · 2000
Descendant · cites it directly · 7 of its ownK092101 Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009
Descendant · 2 generations on · 3 of its ownK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
Descendant · 2 generations on · 2 of its ownK172586 Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · Recalled
Descendant · cites it directly · 2 of its ownK041522 Flexi-Stat Disposable Adhesive SPO2 SensorsElekon Industries U.S.A., Inc. · 2004
Descendant · cites it directly · 2 of its ownK041647 Flexi-Stat Reusable Finger Clip SPO2 Sensors…Elekon Industries U.S.A., Inc. · 2004

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2004high 5 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 14 · See all

K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009 · cites it directly7descendants
K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · 2 generations on3descendants
K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018 · 2 generations on2descendants
K041522Flexi-Stat Disposable Adhesive SPO2 SensorsElekon Industries U.S.A., Inc. · 2004 · cites it directly2descendants
K041647Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible)…Elekon Industries U.S.A., Inc. · 2004 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K992215	Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult…	Envitec-Wismar GmbH	2000	—
+1	K092101	Reusable Pulse Oximeter Sensor, Model 8000 Series	Nonin Medical, Inc.	2009	—
+2	K132402	Sensmart Model X-100 Univeral Oximetry System	Nonin Medical, Inc.	2014	1
+2	K172586	Vios Monitoring System™ Model 2050	Vios Medical, Inc.	2018	4
+1	K041522	Flexi-Stat Disposable Adhesive SPO2 Sensors	Elekon Industries U.S.A., Inc.	2004	—
+1	K041647	Flexi-Stat Reusable Finger Clip SPO2 Sensors…	Elekon Industries U.S.A., Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	5	0
2006	1	0
2009	1	0
2014	1	0
2016	1	0
2018	1	0
2020	1	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K992215, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K092101	Reusable Pulse Oximeter Sensor, Model 8000 Series	Nonin Medical, Inc.	2009	7
K041522	Flexi-Stat Disposable Adhesive SPO2 Sensors	Elekon Industries U.S.A., Inc.	2004	2
K041647	Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible)…	Elekon Industries U.S.A., Inc.	2004	2
K041644	Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)…	Elekon Industries U.S.A., Inc.	2004	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?

Of its descendants, K092101 (Nonin Medical, Inc., 2009) has gone furthest, with 7 descendants of its own.

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?

Continuous or spot monitoring of non-invasive arterial oxygen saturation.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992215 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992215: Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable Sensor, Multicompatible Envitec Ped.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992215

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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