510(k) Report

510(k) · Cleared

Cleared

ElintMAX Respiratory Monitor (ElintMAX Monitor A1)

K260226510(k) TraditionalCleared Sep 16, 2026233-day reviewClass II21 CFR 868.1850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Amptron Medical, Inc. · BZK Spirometer, Monitoring (W/Wo Alarm)

Cleared on Sep 16, 2026 as substantially equivalent to K173181 (Respiratory Motion, Inc., 2018) after a 233-day review. Its family tree reaches back 26 generations to 1994.

Decided
Sep 16, 2026
Review
233 days
Class
Class II
Product code
BZK
Recalls
None
Predicates
1

Its longest line of descent runs back 26 generations to K941811 (1994). 152 ancestors in all, the oldest K844187 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2006: 2 other ancestors2004: 10 other ancestors2002: 10 other ancestors2005: 1 other ancestor2003: 8 other ancestors2000: 19 other ancestors1999: 9 other ancestors1998: 13 other ancestors1997: 7 other ancestors1996: 8 other ancestors1992: 6 other ancestors1991: 6 other ancestors2001: 5 other ancestors1995: 5 other ancestors1994: 2 other ancestors1993: 5 other ancestors1990: 5 other ancestors1989: 2 other ancestors1987: 1 other ancestor1985: 1 other ancestorReference device: K091853 · Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014 · Nspire Health, Inc. · 2009Reference device: K030722 · Envoy Patient Monitor · Mennen Medical, Inc. · 2004K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) ×17: 17 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003), K040304 (2004), K041235 (2004), K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006), K060221 (2006), K060541 (2006) K120087 · Exspiron · Respiratory Motion, Inc. · 2012K130170 · Exspiron 1XI · Respiratory Motion, Inc. · 2013K162131 · ExSpiron 1Xi · Respiratory Motion, Inc. · 2017K173181 · ExSpiron 1Xi · Respiratory Motion, Inc. · 20181990200020102020
Other ancestors, by generation 5 generations back: 1 other ancestor6 generations back: 3 other ancestors7 generations back: 27 other ancestors8 generations back: 48 other ancestors9 generations back: 22 other ancestors10 generations back: 11 other ancestors11 generations back: 11 other ancestors12 generations back: 3 other ancestors K173181 · ExSpiron 1Xi · Respiratory Motion, Inc. · 2018K162131 · ExSpiron 1Xi · Respiratory Motion, Inc. · 2017K130170 · Exspiron 1XI · Respiratory Motion, Inc. · 2013K120087 · Exspiron · Respiratory Motion, Inc. · 2012K060541 · The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors · Philips Medizin Systeme Boblingen GmbH · 2006 · recalledK060221 · The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K053522 · Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 · Philips Medizin Systeme Boeblingen GmbH · 2006K052801 · Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K051106 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K050762 · Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K050141 · The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K042845 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boblingen GmbH · 2004K041235 · Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2004K040304 · Philips Intellivue Patient Monitor, Models MP40 & MP50 · Philips Medizin Systeme Boeblingen GmbH · 2004K032858 · The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. · Philips Medizin Systeme Boblingen GmbH · 2003K031481 · The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 · Philips Medizin Systeme Boblingen GmbH · 2003K030038 · Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr · Philips Medical Systems, Inc. · 2003K023871 · M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology · Philips Medical Systems · 2002K021778 · Philips Component Compact Monitor, Release a.04, Model #M1275B · Philips Medical Systems · 2002K020531 · Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B · Philips Medical Systems · 2002K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−25−20−15−10−50
  1. Root · 26 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 22 generations between
  3. 3 generations backK130170 Exspiron 1XIRespiratory Motion, Inc. · 2013
  4. 2 generations backK162131 ExSpiron 1XiRespiratory Motion, Inc. · 2017
  5. 1 generation backK173181 ExSpiron 1XiRespiratory Motion, Inc. · 2018
  6. This deviceK260226 ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc. · 2026
Show all 26 generations
  1. Root · 26 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 25 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 24 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 23 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 22 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 21 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 20 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 19 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 18 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 17 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 16 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 15 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 14 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 13 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 12 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 11 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 10 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 9 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 8 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 7 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 6 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 5 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 4 generations backK120087 ExspironRespiratory Motion, Inc. · 2012
  24. 3 generations backK130170 Exspiron 1XIRespiratory Motion, Inc. · 2013
  25. 2 generations backK162131 ExSpiron 1XiRespiratory Motion, Inc. · 2017
  26. 1 generation backK173181 ExSpiron 1XiRespiratory Motion, Inc. · 2018
  27. This deviceK260226 ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−26K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−25K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−24K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−23K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−22K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−21K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−20K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−19K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−18K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−17K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−16K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−15K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−14K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−13K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−12K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−11K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−10K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−9K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−8K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−7K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−6K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−5K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−4K120087ExspironRespiratory Motion, Inc.2012—
−3K130170Exspiron 1XIRespiratory Motion, Inc.2013—
−2K162131ExSpiron 1XiRespiratory Motion, Inc.2017—
−1K173181ExSpiron 1XiRespiratory Motion, Inc.2018—
0 (this device)K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
198920
199050
199160
199260
199350
199420
199550
199680
199770
1998130
199990
2000190
200150
2002100
200380
2004100
200510
200620
200910
FIG. 1 — Lineage of K260226, 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), 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 BZK? 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? (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
*K173181ExSpiron 1Xi
Summary page 5
…ification Name: Monitoring Spirometer (21 CFR 868.1850) Regulatory Class: Class II Product Code: BZK, BZQ III. PREDICATE DEVICE Predicate Device (K173181): Trade Name: ExSpiron 1Xi, Common Name: Respiratory Monitor Classification Name: Monitoring Spirome…
Respiratory Motion, Inc.2018—
†K091853Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014Nspire Health, Inc.2009—
†K030722Envoy Patient MonitorMennen Medical, Inc.2004—

Also cleared against K173181: 1 other device →

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 32 years and passes through 8 companies; a new generation was cleared every 4 months on median.
  • 15 of the 152 ancestors have a recall of any class.
  • 1 other device also cites its predicate K173181.

How does its category compare?

All BZK devices

BZK Spirometer, Monitoring (W/Wo Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · BZK

2in 2019

2008: 12009: 32011: 12012: 12013: 12017: 12018: 22019: 22026 (partial year): 1
2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZK

71in 2009

2009: 71 days median
2007high 71 (2009)2026

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

Recalls per year · BZK

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · BZK

2in 2020

2009: 12012: 12013: 732014: 312015: 122016: 12017: 12018: 12020: 2
2007high 73 (2013) · low 0 (2007)2025

MAUDE reports naming product code BZK, 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
20081—00
200937101
20100—00
20111—20
20121—01
20131—073
20140—031
20150—012
20160—01
20171—01
20182—01
20192—00
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20261—0—

What is it indicated for?

ElintMAX is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in spontaneously breathing adult patients who are hemodynamically stable and are not under active procedural or post-anesthesia sedation. ElintMAX is not indicated for use in intensive care or critical care settings, or during the immediate post-anesthesia recovery period. ElintMAX is a non-invasive monitor that graphically displays changes in lung…

Read the full statement (132 words)

ElintMAX is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in spontaneously breathing adult patients who are hemodynamically stable and are not under active procedural or post-anesthesia sedation. ElintMAX is not indicated for use in intensive care or critical care settings, or during the immediate post-anesthesia recovery period.

ElintMAX is a non-invasive monitor that graphically displays changes in lung volume over time and presents estimated values for:

• Tidal Volume

• Respiratory Rate

• Minute Ventilation

• Inspiration-to-Expiration Time Ratio (I:E Ratio)

• Rapid Shallow Breathing Index (RSBI)

ElintMAX is not intended for apnea detection. The device is intended to supplement, not replace, clinical judgment or other diagnostic tools. Its outputs are to be used as supportive inputs in conjunction with other clinical assessments to evaluate respiratory status.

Indications for use as stated in the FDA summary.

Also cleared against K173181

1 other device cites the same predicate.

  • K192595ExSpiron 2XiRespiratory Motion · 2019

Recent decisions in BZK

The BZK category page

  • K192584BEACON Caresystem Model 00002144Mermaid Care A/S · 2019
  • K192595ExSpiron 2XiRespiratory Motion · 2019
  • K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
  • K173181ExSpiron 1XiRespiratory Motion, Inc. · 2018
  • K162131ExSpiron 1XiRespiratory Motion, Inc. · 2017

https://510kreport.com/device/K260226 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260226: ElintMAX Respiratory Monitor (ElintMAX Monitor A1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260226

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026