510(k) Report

510(k) · Cleared

Cleared

Microprocessor Ventilator 7200

K833786510(k) TraditionalCleared Dec 22, 198355-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

Puritan Bennett Corp. · CBK Ventilator, Continuous, Facility Use

Cleared on Dec 22, 1983 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 of the 87 devices in its family, counting itself, have a Class I recall. 86 later devices descend from it.

Decided
Dec 22, 1983
Review
55 days
Class
Class II
Product code
CBK
Recalls
None
Predicates
0

86 later devices descend from it, 1 citing it directly. 14 of the 87 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1996: 2 descendants cleared1999: 2 descendants cleared1998: 2 descendants cleared2007: 4 descendants cleared, 1 with a Class I recall12002: 2 descendants cleared, 1 with a Class I recall12009: 6 descendants cleared, 1 with a Class I recall12010: 5 descendants cleared, 1 with a Class I recall12011: 10 descendants cleared, 3 with a Class I recall32005: 1 descendant cleared2006: 2 descendants cleared2012: 8 descendants cleared, 2 with a Class I recall22008: 3 descendants cleared, 1 with a Class I recall12014: 2 descendants cleared2015: 4 descendants cleared, 1 with a Class I recall12021: 3 descendants cleared, 1 with a Class I recall12020: 3 descendants cleared2019: 2 descendants cleared, 1 with a Class I recall12022: 2 descendants cleared2004: 3 descendants cleared, 1 with a Class I recall12026: 4 descendants cleared2013: 2 descendants cleared2024: 5 descendants cleared2017: 1 descendant cleared2025: 4 descendants cleared2023: 3 descendants cleared2018: 1 descendant cleared19801990200020102020
  1. This deviceK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
  2. Descendant · cites it directly · 85 of its ownK951264 Bipap Model S/T-DRespironics, Inc. · 1996
  3. Descendant · 2 generations on · 58 of its ownK991648 Reusable Contour II Nasal MaskRespironics, Inc. · 1999
  4. Descendant · 2 generations on · 44 of its ownK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
  5. Descendant · 3 generations on · 42 of its ownK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
  6. Descendant · 3 generations on · 28 of its ownK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

1996: 21998: 21999: 22002: 22004: 32005: 12006: 22007: 42008: 32009: 62010: 52011: 102012: 82013: 22014: 22015: 42017: 12018: 12019: 22020: 32021: 32022: 22023: 32024: 52025: 42026: 4
1996high 10 (2011) · low 0 (1997)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 86 · See all
  • K951264Bipap Model S/T-DRespironics, Inc. · 1996 · cites it directly85descendants
  • K991648Reusable Contour II Nasal MaskRespironics, Inc. · 1999 · 2 generations on58descendants
  • K955324Bipap S/T-D 30 SystemRespironics, Inc. · 1996 · 2 generations on44descendants
  • K982454Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · 3 generations on42descendants
  • K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 3 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K833786Microprocessor Ventilator 7200Puritan Bennett Corp.1983—
+1K951264Bipap Model S/T-DRespironics, Inc.1996—
+2K991648Reusable Contour II Nasal MaskRespironics, Inc.1999—
+2K955324Bipap S/T-D 30 SystemRespironics, Inc.1996—
+3K982454Bipap Vision Ventilatory SupportRespironics, Inc.19982
+3K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group20072

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199820
199920
200221
200431
200510
200620
200741
200831
200961
201051
2011103
201282
201320
201420
201541
201710
201810
201921
202030
202131
202220
202330
202450
202540
202640
FIG. 1 — Lineage of K833786, 1983–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

14 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
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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? (86)

See all 86

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

NumberDeviceApplicantDecidedDescendants
K951264Bipap Model S/T-DRespironics, Inc.199685

Has anything in its family been recalled? (14 Class I)

No FDA recall names this device.

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.

  • K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
  • K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
  • K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · 4 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
  • K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
  • K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
  • K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 5 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
  • K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
  • K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
  • K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
  • K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
  • K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
  • K140980TI Nasal MaskRespironics, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall

Nearest 12 of 14 shown.

What does this lineage say?

  • Of its descendants, K951264 (Respironics, Inc., 1996) has gone furthest, with 85 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)—
Cite this page

510(k) Report. “K833786: Microprocessor Ventilator 7200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K833786

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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