510(k) Report

510(k) · Cleared

Cleared

Dura-Y Oxygen Transducer, Ear Clip

K944760510(k) TraditionalCleared Oct 17, 199420-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

Nellcor, Inc. · DPZ Oximeter, Ear

Cleared on Oct 17, 1994 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 54 later devices descend from it.

Decided
Oct 17, 1994
Review
20 days
Class
Class II
Product code
DPZ
Recalls
None
Predicates
0

54 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 1 descendant cleared2001: 1 descendant cleared2012: 2 descendants cleared2010: 2 descendants cleared2011: 1 descendant cleared2006: 2 descendants cleared2015: 4 descendants cleared2014: 1 descendant cleared2024: 2 descendants cleared2017: 4 descendants cleared2013: 1 descendant cleared2016: 2 descendants cleared2018: 4 descendants cleared2019: 4 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2022: 3 descendants cleared2023: 6 descendants cleared2026: 5 descendants cleared2025: 6 descendants cleared1990200020102020
  1. This deviceK944760 Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc. · 1994
  2. Descendant · cites it directly · 45 of its ownK012992 Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of…Masimo Corp. · 2001
  3. Descendant · 2 generations on · 38 of its ownK111621 Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS…Masimo Corporation · 2011
  4. Descendant · 2 generations on · 37 of its ownK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
  5. Descendant · 3 generations on · 34 of its ownK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015 · Recalled
  6. Descendant · 4 generations on · 31 of its ownK161531 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and…Philips Medizin Systeme Boeblingen GmbH · 2016 · Recalled

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12005: 12006: 22010: 22011: 12012: 22013: 12014: 12015: 42016: 22017: 42018: 42019: 42020: 12021: 12022: 32023: 62024: 22025: 62026: 5
2001high 6 (2023) · low 0 (2002)2026

Most influential descendants

Showing 5 of 54 · See all
  • K012992Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and CablesMasimo Corp. · 2001 · cites it directly45descendants
  • K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation · 2011 · 2 generations on38descendants
  • K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012 · 2 generations on37descendants
  • K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH · 2015 · 3 generations on34descendants
  • K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH · 2016 · 4 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944760Dura-Y Oxygen Transducer, Ear ClipNellcor, Inc.1994—
+1K012992Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors…Masimo Corp.2001—
+2K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry…Masimo Corporation2011—
+2K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation2012—
+3K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH20151
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH20161

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200510
200620
201020
201110
201220
201310
201410
201540
201620
201740
201840
201940
202010
202110
202230
202360
202420
202560
202650
FIG. 1 — Lineage of K944760, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (54)

See all 54

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

NumberDeviceApplicantDecidedDescendants
K012992Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and CablesMasimo Corp.200145
K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH20055
K042675Flexi-Stat SP02 Ear SensorElekon Industries U.S.A., Inc.20041

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, K012992 (Masimo Corp., 2001) has gone furthest, with 45 descendants of its own.

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

2010: 12011: 1
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

2009: 12010: 12011: 132012: 42013: 222014: 432015: 62016: 52017: 42018: 42019: 22021: 12022: 22024: 12025: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—11
20110—113
20120—04
20130—022
20140—043
20150—06
20160—05
20170—04
20180—04
20190—02
20200—00
20210—01
20220—02
20230—00
20240—01
20250—01
20260—0—

More from Nellcor, Inc.

18 FDA decisions under this applicant name. See the company

  • K953472Nellcor Symphony N-3100 Blood Pressure MonitorNellcor, Inc. · 1995
  • K952316Nellcor Symphony N-3000 Pulse OximeterNellcor, Inc. · 1995
  • K952222Nellcor N-20PA Portable Pulse OximeterNellcor, Inc. · 1995
  • K942347Nellcor Symphony Pulse Oximeter Model N-3000Nellcor, Inc. · 1995
  • K945947Nellcor Symphony (TM) N-3100 Blood Pressure Monitor and Connected to the Nellcor Symphony (TM) N-3000 Pulse…Nellcor, Inc. · 1995

Recent decisions in DPZ

The DPZ category page

  • K042675Flexi-Stat SP02 Ear SensorElekon Industries U.S.A., Inc. · 2004
  • K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 20043 Class I recalls
  • K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001
  • K010718Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc. · 2001
  • K942752Marquette Ear Probe SensorMarquette Electronics, Inc. · 1994

https://510kreport.com/device/K944760 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944760: Dura-Y Oxygen Transducer, Ear Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944760

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026