510(k) Report

510(k) · Cleared

Cleared

Oximax Max-Fast Adhesive Forehead Sensor

K021089510(k) TraditionalCleared Jun 19, 200276-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

Nellcor Puritan Bennett, Inc. · DQA Oximeter

Cleared on Jun 19, 2002 as substantially equivalent to K012891 (Nellcor Puritan Bennett, Inc., 2002) after a 76-day review. Its family tree reaches back 5 generations to 1997. 13 later devices descend from it.

Decided
Jun 19, 2002
Review
76 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K962603 (1997). 9 ancestors in all, the oldest K904039 (1990). 13 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1995: 1 other ancestor1990: 1 other ancestor1996: 1 other ancestor2004: 1 descendant cleared2006: 1 descendant cleared2013: 1 descendant cleared2005: 2 descendants cleared2016: 1 descendant cleared2007: 1 descendant cleared2019: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant clearedK962603 · 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. · 1999K012891 · Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories) · Nellcor Puritan Bennett, Inc. · 2002 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K012891 · Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories) · Nellcor Puritan Bennett, Inc. · 2002 · recalledK991823 · 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 · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
  2. 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
  3. 3 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
  4. 2 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
  5. 1 generation backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
  6. This deviceK021089 Oximax Max-Fast Adhesive Forehead SensorNellcor Puritan Bennett, Inc. · 2002
  7. Descendant · cites it directly · 3 of its ownK122996 Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale · 2013
  8. Descendant · cites it directly · 3 of its ownK052186 Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I…Nellcor Puritan Bennett, Inc. · 2005
  9. Descendant · 2 generations on · 2 of its ownK143216 Assurance Alar / Nasal SpO2 SensorXhale, Inc. · 2015 · Recalled
  10. Descendant · 2 generations on · 1 of its ownK181738 Medline ReNewal Reprocessed OxiMax Pulse Oximetry SensorsSurgical Instrument Service and Savings Inc (Dba Medline · 2019
  11. Descendant · 3 generations on · 1 of its ownK171423 Nasal Alar SpO2 SensorXhale, Inc. · 2017 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 12007: 12011: 12013: 12015: 12016: 12017: 12019: 12020: 12026: 1
2004high 2 (2005) · low 0 (2008)2026

Most influential descendants

Showing 5 of 13 · See all
  • K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale · 2013 · cites it directly3descendants
  • K052186Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-PNellcor Puritan Bennett, Inc. · 2005 · cites it directly3descendants
  • K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc. · 2015 · 2 generations on2descendants
  • K181738Medline ReNewal Reprocessed OxiMax Pulse Oximetry SensorsSurgical Instrument Service and Savings Inc (Dba Medline · 2019 · 2 generations on1descendant
  • K171423Nasal Alar SpO2 SensorXhale, Inc. · 2017 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K962603Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp.1997—
−4K973887Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and CablesMasimo Corp.1998—
−3K982255Model 2000 Pulse OximeterIvy Biomedical Systems, Inc.1998—
−2K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc.1999—
−1K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and…Nellcor Puritan Bennett, Inc.20021
0 (this device)K021089Oximax Max-Fast Adhesive Forehead SensorNellcor Puritan Bennett, Inc.2002—
+1K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale2013—
+1K052186Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-PNellcor Puritan Bennett, Inc.2005—
+2K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.20151
+2K181738Medline ReNewal Reprocessed OxiMax Pulse Oximetry SensorsSurgical Instrument Service and Savings Inc (Dba Medline2019—
+3K171423Nasal Alar SpO2 SensorXhale, Inc.20171

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199510
199610
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200610
200710
201110
201310
201510
201610
201710
201910
202010
202610
FIG. 1 — Lineage of K021089, 1997–2026Source: 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), 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
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Nellcor Puritan Bennett, Inc.20021

Also cleared against K012891: 33 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133
K052186Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-PNellcor Puritan Bennett, Inc.20053
K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051
K032551Masimo Lnop-TF-I Resuable Transflectance SensorMasimo Corp.20041
K051271Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorNellcor Puritan Bennett, Inc.20060

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 5 years and passes through 3 companies; a new generation was cleared every 10 months on median.
  • 3 of the 9 ancestors have a recall of any class.
  • Of its descendants, K122996 (Xhale, 2013) has gone furthest, with 3 descendants of its own.
  • 33 other devices also cite its predicate K012891.

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 Nellcor OxiMAX adhesive forehead reflectance sensor, model MAX-FAST, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adult or pediatric (2 10 kg) patients.

Indications for use as stated in the FDA summary.

Also cleared against K012891

33 other devices cite the same predicate.

  • K212555Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHCCovidien, LLC · 2022
  • K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse…Stryker Sustainability Solutions · 2022
  • K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care…Bluepoint Medical GmbH & Co. KG · 2017
  • K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare · 2015
  • K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring System with…Covidien · 2014
  • K123581Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside…Covidien, Formerly Nellcor Puritan Bennett, Inc. · 20132 recalls

More from Nellcor Puritan Bennett, Inc.

49 FDA decisions under this applicant name. See the company

  • K070408Duramax Reusable Oximetry SensorNellcor Puritan Bennett, Inc. · 2007
  • K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc. · 2006
  • K051271Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorNellcor Puritan Bennett, Inc. · 2006
  • K052186Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-PNellcor Puritan Bennett, Inc. · 2005
  • K051352Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc. · 2005

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/K021089 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021089: Oximax Max-Fast Adhesive Forehead Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021089

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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