510(k) Report

510(k) · Cleared

Recalled · Class I · 2017

Newport HT70 Family of Ventilators

K090888510(k) TraditionalCleared Nov 18, 2009232-day reviewClass II21 CFR 868.5895Recalls 4 (3 Class I)

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

Newport Medical Instruments, Inc. · CBK Ventilator, Continuous, Facility Use

Cleared on Nov 18, 2009 as substantially equivalent to K992133 (Newport Medical Instruments, Inc., 2000) and 17 other predicates after a 232-day review. Its family tree reaches back 11 generations to 1991. 9 of the 85 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including 3 Class I recalls.

Decided
Nov 18, 2009
Review
232 days
Class
Class II
Product code
CBK
Recalls
4 (3 Class I)
Predicates
18

Its longest line of descent runs back 11 generations to K902859 (1991). 82 ancestors in all, the oldest K841279 (1984). 2 later devices descend from it, 2 citing it directly. 9 of the 85 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2007: 1 other ancestor, 1 with a Class I recall12005: 2 other ancestors2004: 5 other ancestors, 1 with a Class I recall12003: 3 other ancestors, 1 with a Class I recall12001: 6 other ancestors2000: 5 other ancestors, 1 with a Class I recall11999: 6 other ancestors1998: 11 other ancestors, 2 with a Class I recall22006: 1 other ancestor1996: 3 other ancestors1995: 3 other ancestors2002: 3 other ancestors1997: 3 other ancestors1990: 6 other ancestors1984: 1 other ancestor1994: 3 other ancestors1993: 1 other ancestor1991: 4 other ancestors1992: 2 other ancestors1988: 1 other ancestor2012: 1 descendant cleared2011: 1 descendant cleared, 1 with a Class I recall1K902859 · Servo Ventilator 300 · Siemens Life Support Systems · 1991 · recalledK960010 · Servo Ventilator 300 Computer Interface · Siemens Elema AB · 1996K970839 · Servo Ventilator 300A · Siemens Elema AB · 1997 · recalledK992788 · Bear Cub 750 PSV · Bear Medical Systems, Inc. · 1999K013642 · AVEA · Bird Products Corp. · 2002 · Class I recallK032451 · Bird Tbird Vela Ventilator · Bird Products Corp. · 2004 · recalled×3: 3 generations cleared close together, K052554 (2005), K053270 (2006), K061627 (2006) K063404 · Servo-I Ventilator System, Models 64, 87 and 800 · Maquet Critical Care AB · 2007K073694 · Ivent 2001 Mri Conditional · Versamed Medical Systems, Inc. · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors, 1 with a Class I recall12 generations back: 6 other ancestors3 generations back: 13 other ancestors, 3 with a Class I recall34 generations back: 15 other ancestors, 1 with a Class I recall15 generations back: 15 other ancestors6 generations back: 7 other ancestors, 1 with a Class I recall17 generations back: 1 other ancestor 1 generation forward: 2 descendants, 1 with a Class I recall1 K073694 · Ivent 2001 Mri Conditional · Versamed Medical Systems, Inc. · 2008K063404 · Servo-I Ventilator System, Models 64, 87 and 800 · Maquet Critical Care AB · 2007K061627 · Modification to I Vent 201 · Versamed Medical Systems, Inc. · 2006K053270 · IVENT 201 · Versamed Medical Systems, Inc. · 2006K052554 · Modification to: Ivent 201 Portable Ventilator · Versamed Medical Systems, Inc. · 2005K032451 · Bird Tbird Vela Ventilator · Bird Products Corp. · 2004 · recalledK013642 · AVEA · Bird Products Corp. · 2002 · Class I recallK992788 · Bear Cub 750 PSV · Bear Medical Systems, Inc. · 1999K970839 · Servo Ventilator 300A · Siemens Elema AB · 1997 · recalledK960010 · Servo Ventilator 300 Computer Interface · Siemens Elema AB · 1996K902859 · Servo Ventilator 300 · Siemens Life Support Systems · 1991 · recalled−10−50
  1. Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
  2. 7 generations between
  3. 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
  4. 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
  5. 1 generation backK073694 Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc. · 2008
  6. This deviceK090888 Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009
  7. Descendant · cites it directly · 1 of its ownK111146 Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · Recalled (Class I)
  8. Descendant · cites it directly · 0 of its ownK121891 Newport Aura VentilatorNewport Medical Instruments, Inc. · 2012
Show all 11 generations
  1. Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
  2. 10 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
  3. 9 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
  4. 8 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
  5. 7 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
  6. 6 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
  7. 5 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
  8. 4 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
  9. 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
  10. 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
  11. 1 generation backK073694 Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc. · 2008
  12. This deviceK090888 Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009

Class I recalls in this family

  • K070594 Palmtop Ventilator, Models PTV-8, PTV-10direct predicate · 2007
  • K041223 Modification to Servo-I Ventilator System, Model…3 generations back · 2004
  • K023366 Datex-Ohmeda 7900 Ventilator Enhancements3 generations back · 2003
  • K013642 AVEA3 generations back · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · cites it directly1descendant
  • K121891Newport Aura VentilatorNewport Medical Instruments, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K902859Servo Ventilator 300Siemens Life Support Systems19913
−10K960010Servo Ventilator 300 Computer InterfaceSiemens Elema AB1996—
−9K970839Servo Ventilator 300ASiemens Elema AB19974
−8K992788Bear Cub 750 PSVBear Medical Systems, Inc.1999—
−7K013642AVEABird Products Corp.2002Class I
−6K032451Bird Tbird Vela VentilatorBird Products Corp.20041
−5K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc.2005—
−4K053270IVENT 201Versamed Medical Systems, Inc.2006—
−3K061627Modification to I Vent 201Versamed Medical Systems, Inc.2006—
−2K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB2007—
−1K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.2008—
0 (this device)K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.2009—
+1K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.2011Class I
+1K121891Newport Aura VentilatorNewport Medical Instruments, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198810
199060
199140
199220
199310
199430
199530
199630
199730
1998112
199960
200051
200160
200230
200331
200451
200520
200610
200711
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201111
201210
FIG. 1 — Lineage of K090888, 1991–2012Source: 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.

9 devices in this family have a Class I recall. 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 CBK device

  1. #1 K252663 Inbentus Versatilescore 16.0 · 17 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? (18)

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
*K992133Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without…
Summary page 1
…The HT70 is substantially equivalent to the following legally marketed predicate devices: * NEWPORT HT50® Ventilator cleared under K992133 and K082724; · Pulmonetic Systems LTV® 1000 cleared under K981371, K984056, K002881, K0…
Newport Medical Instruments, Inc.20005
*K082724Newport HTS50 Ventilator with Dual Pac Battery System
Summary page 1
…e HT70 is substantially equivalent to the following legally marketed predicate devices: * NEWPORT HT50® Ventilator cleared under K992133 and K082724; · Pulmonetic Systems LTV® 1000 cleared under K981371, K984056, K002881, K010608, K0322…
Newport Medical Instruments, Inc.20082
*K981371LTV 1000 Ventilator
Summary page 1
…cate devices: * NEWPORT HT50® Ventilator cleared under K992133 and K082724; · Pulmonetic Systems LTV® 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767; a Pulmonetic Systems PALMTop…
Pulmonetic Systems, Inc.199812
*K984056LTV 1000
Summary page 1
…devices: * NEWPORT HT50® Ventilator cleared under K992133 and K082724; · Pulmonetic Systems LTV® 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767; a Pulmonetic Systems PALMTop PTV Mode…
Pulmonetic Systems, Inc.199912
*K002881Ventilator, Continuous (Respirator), Model LTV 1000
Summary page 1
…ces: * NEWPORT HT50® Ventilator cleared under K992133 and K082724; · Pulmonetic Systems LTV® 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767; a Pulmonetic Systems PALMTop PTV Models 8/10 c…
Pulmonetic Systems, Inc.200012
*K010608Modification to Lap Top Ventilator (LTV)
Summary page 1
…ORT HT50® Ventilator cleared under K992133 and K082724; · Pulmonetic Systems LTV® 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767; a Pulmonetic Systems PALMTop PTV Models 8/10 cleared under K070594;…
Pulmonetic Systems, Inc.20014
*K032226LTV-1000 Ventilator
Summary page 1
…Ventilator cleared under K992133 and K082724; · Pulmonetic Systems LTV® 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767; a Pulmonetic Systems PALMTop PTV Models 8/10 cleared under K070594;…
Pulmonetic Systems, Inc.20031
*K040540Modification to LTV 1000 Ventilator
Summary page 1
…or cleared under K992133 and K082724; · Pulmonetic Systems LTV® 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767; a Pulmonetic Systems PALMTop PTV Models 8/10 cleared under K070594; and…
Pulmonetic Systems, Inc.20048
*K051767LTV 1000 Ventilator
Summary page 1
…der K992133 and K082724; · Pulmonetic Systems LTV® 1000 cleared under K981371, K984056, K002881, K010608, K032226, K040540, and K051767; a Pulmonetic Systems PALMTop PTV Models 8/10 cleared under K070594; and…
Pulmonetic Systems, Inc.2005—
*K070594Palmtop Ventilator, Models PTV-8, PTV-10
Summary page 1
…r K981371, K984056, K002881, K010608, K032226, K040540, and K051767; a Pulmonetic Systems PALMTop PTV Models 8/10 cleared under K070594; and * Versarmed Medical Systems iVENTIM 201 cleared under K981668, K01 1957,…
Pulmonetic Systems, Inc.2007Class I
*K981668Smartvent 201 Portable Ventilator
Summary page 1
…a Pulmonetic Systems PALMTop PTV Models 8/10 cleared under K070594; and * Versarmed Medical Systems iVENTIM 201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627, and K073694. ht70sub -032609 IV…
Versamed, Ltd.1999—
*K011957Ivent 201 Portable Ventilator
Summary page 1
…netic Systems PALMTop PTV Models 8/10 cleared under K070594; and * Versarmed Medical Systems iVENTIM 201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627, and K073694. ht70sub -032609 IV. Dev…
Versamed, Ltd.2001—
*K021981Ivent 201 Portable Ventilator
Summary page 1
…8/10 cleared under K070594; and * Versarmed Medical Systems iVENTIM 201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627, and K073694. ht70sub -032609 IV. Device Description The Ne…
Versamed, Ltd.2003—
*K042468Ivent 201 Portable Ventilator
Summary page 1
…ared under K070594; and * Versarmed Medical Systems iVENTIM 201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627, and K073694. ht70sub -032609 IV. Device Description The Newport HT7…
Versamed Medical Systems, Inc.2004—
*K052554Modification to: Ivent 201 Portable Ventilator
Summary page 1
…r K070594; and * Versarmed Medical Systems iVENTIM 201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627, and K073694. ht70sub -032609 IV. Device Description The Newport HT70 is a st…
Versamed Medical Systems, Inc.2005—
*K053270IVENT 201
Summary page 1
…; and * Versarmed Medical Systems iVENTIM 201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627, and K073694. ht70sub -032609 IV. Device Description The Newport HT70 is a state of th…
Versamed Medical Systems, Inc.2006—
*K061627Modification to I Vent 201
Summary page 1
…and * Versarmed Medical Systems iVENTIM 201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627, and K073694. ht70sub -032609 IV. Device Description The Newport HT70 is a state of the art ven…
Versamed Medical Systems, Inc.2006—
*K073694Ivent 2001 Mri Conditional
Summary page 1
…and * Versarmed Medical Systems iVENTIM 201 cleared under K981668, K01 1957, K021981, K042468, K052554, K053270, K061627, and K073694. ht70sub -032609 IV. Device Description The Newport HT70 is a state of the art ventilator that…
Versamed Medical Systems, Inc.2008—

Also cleared against K992133: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K111146Newport HT70 Ventilator Class INewport Medical Instruments, Inc.20111
K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120

Has anything in its family been recalled? (9 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 30, 2017Class IZ-1874-2017Software in the Use EnvironmentMedtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm.
Apr 5, 2013Class IZ-1171-2013Component design/selectionNewport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to…
Aug 3, 2012Class IZ-2250-2012Nonconforming Material/ComponentMay emit a continuous high priority alarm and the ventilator may stop ventilating, due to a component failure on the control board.
Sep 20, 2010Not classifiedZ-2406-2011OtherThe recall was initiated because Newport Medical has confirmed a limited number of power cords recently received from their supplier, Glob-Tek, have a slightly oversized plug connector which prevents the cord from locking into place.…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 12 Class I recalls
  • K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
  • K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
  • K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
  • K981072Esprit VentilatorRespironics, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
  • K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
  • K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
  • K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls

Nearest 5 of 8; all are on the web page.

What does this lineage say?

  • The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
  • 29 of the 82 ancestors have a recall of any class; 7 have a Class I recall.
  • Of its descendants, K111146 (Newport Medical Instruments, Inc., 2011) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K992133.

How does its category compare?

All CBK devices

CBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · CBK

4in 2025

2007: 112008: 182009: 122010: 142011: 132012: 172013: 52014: 52015: 72016: 42017: 62018: 42019: 82020: 52021: 62023: 52024: 92025: 42026 (partial year): 3
2007high 18 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBK

163in 2025

2007: 142 days median2008: 115 days median2009: 122 days median2010: 150 days median2011: 192 days median2012: 207 days median2013: 277 days median2014: 439 days median2015: 266 days median2016: 323 days median2017: 280 days median2018: 183 days median2019: 435 days median2020: 176 days median2021: 267 days median2023: 309 days median2024: 203 days median2025: 163 days median2026 (partial year): 235 days median
2007high 439 (2014) · low 115 (2008)2026

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

Recalls per year · CBK

14in 2024

2007: 172008: 232009: 82010: 92011: 122012: 2, 1 Class I2013: 5, 2 Class I2014: 5, 4 Class I2015: 6, 4 Class I2016: 4, 1 Class I2017: 12018: 3, 3 Class I2019: 14, 13 Class I2020: 42021: 21, 19 Class I2022: 8, 4 Class I2023: 4, 3 Class I2024: 14, 14 Class I2026 (partial year): 15, 13 Class I
2007high 23 (2008) · low 0 (2025)2026

Class I (81 since 2007) Class II/III not classified

Adverse event reports per year · CBK

13,991in 2025

2007: 1,5312008: 1,9332009: 1,7662010: 1,7992011: 1,8772012: 5,5092013: 7,9212014: 7,6002015: 11,8762016: 16,0562017: 14,4512018: 9,8492019: 9,1002020: 11,0962021: 13,3222022: 15,9742023: 24,9282024: 20,3362025: 13,991
2007high 24,928 (2023) · low 1,531 (2007)2025

MAUDE reports naming product code CBK, 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
200711142171,531
200818115231,933
20091212281,766
20101415091,799
201113192121,877
2012172072 (1)5,509
201352775 (2)7,921
201454395 (4)7,600
201572666 (4)11,876
201643234 (1)16,056
20176280114,451
201841833 (3)9,849
2019843514 (13)9,100
20205176411,096
2021626721 (19)13,322
20220—8 (4)15,974
202353094 (3)24,928
2024920314 (14)20,336
20254163013,991
2026323515 (13)—

What is it indicated for?

The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs).

The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

Indications for use as stated in the FDA summary.

Also cleared against K992133

3 other devices cite the same predicate.

  • K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd. · 2010
  • K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 20095 Class I recalls
  • K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc. · 20082 recalls

More from Newport Medical Instruments, Inc.

22 FDA decisions under this applicant name. See the company

  • K121891Newport Aura VentilatorNewport Medical Instruments, Inc. · 2012
  • K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 20114 Class I recalls
  • K101803Newport E360 VentilatorNewport Medical Instruments, Inc. · 2010
  • K082724Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc. · 20082 recalls
  • K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc. · 2006

Recent decisions in CBK

The CBK category page

  • K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa · 2026
  • K252663Inbentus VersatileIconic Solutions by Murcia, SL · 2026
  • K251888VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026
  • K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
  • K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P…Fisher & Paykel Healthcare, Ltd. · 2025

https://510kreport.com/device/K090888 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090888: Newport HT70 Family of Ventilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090888

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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