510(k) Report

510(k) · Cleared

Cleared

Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use with Nellcor R-Cal SPO2

K061191510(k) SpecialCleared May 22, 200624-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

Measurement Specialties, Inc. · DQA Oximeter

Cleared on May 22, 2006 as substantially equivalent to K042704 (Elekon Industries U.S.A., Inc., 2004) and 3 other predicates after a 24-day review. Its family tree reaches back 6 generations to 1997.

Decided
May 22, 2006
Review
24 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K962603 (1997). 14 ancestors in all, the oldest K944760 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 3 other ancestors2000: 1 other ancestor1998: 1 other ancestor1996: 2 other ancestors1994: 1 other ancestorK962603 · Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables · Masimo Corp. · 1997K973887 · Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables · Masimo Corp. · 1998K982255 · Model 2000 Pulse Oximeter · Ivy Biomedical Systems, Inc. · 1998K991823 · N-395 Pulse Oximeter, Model N-395 · Nellcor Puritan Bennett, Inc. · 1999K041647 · Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible), (Datex-Compatible) · Elekon Industries U.S.A., Inc. · 2004K042704 · Reusable Finger Clip SPO2 Sensors · Elekon Industries U.S.A., Inc. · 20041990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor K042704 · Reusable Finger Clip SPO2 Sensors · Elekon Industries U.S.A., Inc. · 2004K041647 · Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible), (Datex-Compatible) · Elekon Industries U.S.A., Inc. · 2004K991823 · N-395 Pulse Oximeter, Model N-395 · Nellcor Puritan Bennett, Inc. · 1999K982255 · Model 2000 Pulse Oximeter · Ivy Biomedical Systems, Inc. · 1998K973887 · Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables · Masimo Corp. · 1998K962603 · Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables · Masimo Corp. · 1997−50
  1. Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
  2. 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
  3. 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
  4. 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
  5. 2 generations backK041647 Flexi-Stat Reusable Finger Clip SPO2 Sensors…Elekon Industries U.S.A., Inc. · 2004
  6. 1 generation backK042704 Reusable Finger Clip SPO2 SensorsElekon Industries U.S.A., Inc. · 2004
  7. This deviceK061191 Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric…Measurement Specialties, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K962603Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp.1997—
−5K973887Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and CablesMasimo Corp.1998—
−4K982255Model 2000 Pulse OximeterIvy Biomedical Systems, Inc.1998—
−3K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc.1999—
−2K041647Flexi-Stat Reusable Finger Clip SPO2 Sensors…Elekon Industries U.S.A., Inc.2004—
−1K042704Reusable Finger Clip SPO2 SensorsElekon Industries U.S.A., Inc.2004—
0 (this device)K061191Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors…Measurement Specialties, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199620
199810
200010
200430
FIG. 1 — Lineage of K061191, 1997–2006Source: 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), 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. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K042704Reusable Finger Clip SPO2 Sensors
Summary page 2
…usable; Ear sensor, reusable; Neonatal-Adult sensor, disposable; Adult/Pediatric sensor, disposable) are substantially equivalent to the predicate SpO2 sensors: K042704 Flexi-Stat(tm) Finger clip SpO2 sensor K042675 Flexi-Stat(tm) Ear sensor K042705 All-fit Flexi-Stat(tm) Disp SpO2…
Elekon Industries U.S.A., Inc.2004—
*K042675Flexi-Stat SP02 Ear Sensor
Summary page 2
…sposable; Adult/Pediatric sensor, disposable) are substantially equivalent to the predicate SpO2 sensors: K042704 Flexi-Stat(tm) Finger clip SpO2 sensor K042675 Flexi-Stat(tm) Ear sensor K042705 All-fit Flexi-Stat(tm) Disp SpO2 sensor (Nellcor-compatible) K041522 Flexi-Stat…
Elekon Industries U.S.A., Inc.2004—
*K042705Disposable Non-Adhesive SPO2 Sensors
Summary page 2
…le) are substantially equivalent to the predicate SpO2 sensors: K042704 Flexi-Stat(tm) Finger clip SpO2 sensor K042675 Flexi-Stat(tm) Ear sensor K042705 All-fit Flexi-Stat(tm) Disp SpO2 sensor (Nellcor-compatible) K041522 Flexi-Stat(tm) Disposable Adhesive SpO2 sensor (Nell…
Elekon Industries U.S.A., Inc.2004—
*K041522Flexi-Stat Disposable Adhesive SPO2 Sensors
Summary page 2
…704 Flexi-Stat(tm) Finger clip SpO2 sensor K042675 Flexi-Stat(tm) Ear sensor K042705 All-fit Flexi-Stat(tm) Disp SpO2 sensor (Nellcor-compatible) K041522 Flexi-Stat(tm) Disposable Adhesive SpO2 sensor (Nellcor-compatible) DEVICE DESCRIPTION as required by 807.92(a)(4) SpO2 sensors…
Elekon Industries U.S.A., Inc.2004—

What descends from it?

No later submission names this one as a predicate yet.

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 9 years and passes through 5 companies; a new generation was cleared every 11 months on median.
  • None of the 14 ancestors has a 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

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
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

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

What is it indicated for?

The Finger Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg. The Ear Sensor for use with Nellcor& R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 10 kg. The Neonatal-Adult Sensor for use with NellcorS R-cal SpO2 is indicated for…

Read the full statement (112 words)

The Finger Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.

The Ear Sensor for use with Nellcor& R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 10 kg.

The Neonatal-Adult Sensor for use with NellcorS R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.

The Adult/Pediatric Sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.

Indications for use as stated in the FDA summary.

More from Measurement Specialties, Inc.

2 FDA decisions under this applicant name. See the company

  • K010706Thinner Resolve Fitness Monitor/Body Scale, Health-O-MeterMeasurement Specialties, Inc. · 2001

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K061191 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061191: Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use with Nellcor R-Cal SPO2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061191

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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