510(k) Report

510(k) · Cleared

Cleared

smart-sync

K212271510(k) TraditionalCleared Feb 4, 2022199-day reviewClass II21 CFR 892.1000

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

Northh Medical GmbH · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Feb 4, 2022 as substantially equivalent to K981190 (GE Medical Systems, 1998) and 1 other predicate after a 199-day review. Its family tree reaches back 31 generations to 1994.

Decided
Feb 4, 2022
Review
199 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
2

Its longest line of descent runs back 31 generations to K941811 (1994). 197 ancestors in all, the oldest K832113 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 15 other ancestors2006: 5 other ancestors2005: 3 other ancestors2004: 15 other ancestors2002: 13 other ancestors2007: 1 other ancestor2003: 13 other ancestors2001: 7 other ancestors2000: 20 other ancestors1995: 9 other ancestors1994: 3 other ancestors1999: 10 other ancestors1997: 8 other ancestors1996: 11 other ancestors1993: 6 other ancestors1992: 6 other ancestors1991: 7 other ancestors1990: 6 other ancestors1989: 3 other ancestors1988: 1 other ancestor1987: 2 other ancestors1983: 1 other ancestor1985: 1 other ancestorReference device: K140535 · Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50 · Philips Medizin Systeme Boblingen GmbH · 2014 · recalledK941811 · 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) ×20: 20 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), K061052 (2006), K061610 (2006), K063315 (2006) ×2: 2 generations cleared close together, K071426 (2007), K072070 (2007) K081937 · Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry Module · Philips Medizin Systeme Boeblingen GmbH · 2008K090785 · Mri Compatible Patient Monitoring System, Model 865214 · Invivo Corp. · 2009 · recalledK124061 · Mri Patient Monitoring System (Model 865214) · Invivo Corporation · 2013 · recalledK152330 · Expression MR400 MRI Patient Monitoring System · Invivo Corporation · 2015 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 6 other ancestors6 generations back: 14 other ancestors7 generations back: 34 other ancestors8 generations back: 33 other ancestors9 generations back: 26 other ancestors10 generations back: 16 other ancestors11 generations back: 14 other ancestors12 generations back: 12 other ancestors13 generations back: 8 other ancestors14 generations back: 1 other ancestor K152330 · Expression MR400 MRI Patient Monitoring System · Invivo Corporation · 2015 · recalledK124061 · Mri Patient Monitoring System (Model 865214) · Invivo Corporation · 2013 · recalledK090785 · Mri Compatible Patient Monitoring System, Model 865214 · Invivo Corp. · 2009 · recalledK081937 · Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry Module · Philips Medizin Systeme Boeblingen GmbH · 2008K072070 · Philips MP2 and X2 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K071426 · MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient Monitors · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007K063315 · Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2006K061610 · Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K061052 · The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 · Philips Medical Systems North America, Inc. · 2006K060541 · 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. · 1994−30−25−20−15−10−50
  1. Root · 31 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 27 generations between
  3. 3 generations backK090785 Mri Compatible Patient Monitoring System, Model 865214Invivo Corp. · 2009 · Recalled
  4. 2 generations backK124061 Mri Patient Monitoring System (Model 865214)Invivo Corporation · 2013 · Recalled
  5. 1 generation backK152330 Expression MR400 MRI Patient Monitoring SystemInvivo Corporation · 2015 · Recalled
  6. This deviceK212271 smart-syncNorthh Medical GmbH · 2022
Show all 31 generations
  1. Root · 31 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 30 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 29 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 28 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 27 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 26 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 25 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 24 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 23 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 22 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 21 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 20 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 19 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 18 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 17 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 16 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 15 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 14 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 13 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 12 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 11 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 10 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 9 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 8 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  25. 7 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
  26. 6 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  27. 5 generations backK072070 Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
  28. 4 generations backK081937 Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules…Philips Medizin Systeme Boeblingen GmbH · 2008
  29. 3 generations backK090785 Mri Compatible Patient Monitoring System, Model 865214Invivo Corp. · 2009 · Recalled
  30. 2 generations backK124061 Mri Patient Monitoring System (Model 865214)Invivo Corporation · 2013 · Recalled
  31. 1 generation backK152330 Expression MR400 MRI Patient Monitoring SystemInvivo Corporation · 2015 · Recalled
  32. This deviceK212271 smart-syncNorthh Medical GmbH · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−31K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−30K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−29K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−28K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−27K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−26K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−25K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−24K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−23K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−22K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−21K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−20K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−19K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−18K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−17K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−16K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−15K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−14K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−13K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−12K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−11K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−10K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−9K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−8K061610Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−7K063315Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80…Philips Medizin Systeme Boeblingen GmbH2006—
−6K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−5K072070Philips MP2 and X2 Intellivue Patient MonitorsPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2007—
−4K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse…Philips Medizin Systeme Boeblingen GmbH2008—
−3K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.20096
−2K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation20131
−1K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation20151
0 (this device)K212271smart-syncNorthh Medical GmbH2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198720
198810
198930
199060
199170
199260
199360
199430
199590
1996110
199780
1998150
1999100
2000200
200170
2002130
2003130
2004150
200530
200650
200710
FIG. 1 — Lineage of K212271, 1994–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 LNH? 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 LNH device

  1. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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? (2)

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
*K981190High Impedance Cardiac Gating Cable
Summary page 4
…Date High Impedance Cardiac Gating Cable GE Medical Systems K981190 06/30/1998 Additional Predicate Device Due to technological differences to the primary predicate device, an additiona…
GE Medical Systems1998—
*K152330Expression MR400 MRI Patient Monitoring System
Summary page 4
…Date Expression MR400 MRI Patient Monitoring Invivo Corporation K152330 12/23/2015 System* * The subject device is compared with the wireless ECG module of the Expression MR400.…
Invivo Corporation20151
†K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH20145

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 28 years and passes through 11 companies; a new generation was cleared every 4 months on median.
  • 24 of the 197 ancestors have a recall of any class.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, 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
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

smart-sync is intended to generate a gating signal for MR scanners (1.5T and 3T) for motion compensation by detecting the heartbeat of a patient using Doppler ultrasound. Thus, smart-sync is intended to improve the image quality by reducing movement artefacts for MR images of the whole body, where motion compensation of the heart movement is necessary.

smart-sync is intended to be used on pregnant women, where the fetus is examined. smart-sync is also intended to be used for adult MR examinations.

smart-sync is not intended to monitor any physiological parameters.

Indications for use as stated in the FDA summary.

Recent decisions in LNH

The LNH category page

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K260092Vista AI ScanVista AI, Inc. · 2026
  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026

https://510kreport.com/device/K212271 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212271: smart-sync.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212271

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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