510(k) Report

510(k) · Cleared

Cleared

Continuous Volume Ventilator Model LP10

K903010510(k) TraditionalCleared Nov 30, 1990142-day reviewClass II21 CFR 868.5895

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

Aequitron Medical, Inc. · CBK Ventilator, Continuous, Facility Use

Cleared on Nov 30, 1990 after a 142-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Nov 30, 1990
Review
142 days
Class
Class II
Product code
CBK
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2004: 2 descendants cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK903010 Continuous Volume Ventilator Model LP10Aequitron Medical, Inc. · 1990
  2. Descendant · cites it directly · 3 of its ownK990177 Nellcor Puritan Bennett Achieva Ventilator and Report GeneratorNellcor Puritan Bennett, Inc. · 1999
  3. Descendant · 2 generations on · 1 of its ownK034032 PLV Continuum Ventilator, Model P2000Respironics California, Inc. · 2004
  4. Descendant · 3 generations on · 0 of its ownK081845 IVENT101Versamed Medical Systems, Inc. · 2009
  5. Descendant · 2 generations on · 0 of its ownK040712 Air Safety Hepa, Model 3500Air Safety, Ltd. · 2004

Most influential descendants

Showing 4 of 4 · See all
  • K990177Nellcor Puritan Bennett Achieva Ventilator and Report GeneratorNellcor Puritan Bennett, Inc. · 1999 · cites it directly3descendants
  • K034032PLV Continuum Ventilator, Model P2000Respironics California, Inc. · 2004 · 2 generations on1descendant
  • K081845IVENT101Versamed Medical Systems, Inc. · 2009 · 3 generations on0descendants
  • K040712Air Safety Hepa, Model 3500Air Safety, Ltd. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903010Continuous Volume Ventilator Model LP10Aequitron Medical, Inc.1990—
+1K990177Nellcor Puritan Bennett Achieva Ventilator and Report GeneratorNellcor Puritan Bennett, Inc.1999—
+2K034032PLV Continuum Ventilator, Model P2000Respironics California, Inc.2004—
+3K081845IVENT101Versamed Medical Systems, Inc.2009—
+2K040712Air Safety Hepa, Model 3500Air Safety, Ltd.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200420
200910
FIG. 1 — Lineage of K903010, 1990–2009Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CBK? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990177Nellcor Puritan Bennett Achieva Ventilator and Report GeneratorNellcor Puritan Bennett, Inc.19993

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?

  • Of its descendants, K990177 (Nellcor Puritan Bennett, Inc., 1999) has gone furthest, with 3 descendants of its own.

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.

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)—

More from Aequitron Medical, Inc.

24 FDA decisions under this applicant name. See the company

  • K961972Model Ami Infant Central Aphea/Heart Rate MonitorAequitron Medical, Inc. · 1997
  • K952880Model LP-1000 Volume VentilatorAequitron Medical, Inc. · 1996
  • K944654Oxygen Concentration IndicatorAequitron Medical, Inc. · 1994
  • K914424Model 6213 Remote AlarmAequitron Medical, Inc. · 1992
  • K915381Portable Oxygen GeneratorAequitron Medical, Inc. · 1992

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/K903010 · printed Nov 5, 2026

Cite this page

510(k) Report. “K903010: Continuous Volume Ventilator Model LP10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903010

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026