510(k) Report

FDA product code · Anesthesiology

Ventilator, Continuous, Facility Use

CBKClass II21 CFR 868.5895510(k) required505 decisions since 1976212 recalls

505 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 267 days (half between 136 and 355). 212 recalls name this code, 81 of them Class I. The most-cited predicate is K961687, named by 11 later devices.

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

FIG. A — Illustration, anesthesiology panel

Twenty years of CBK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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)—
FIG. 1 — CBK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CBK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do CBK devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K961687EVITA 4Drager, Inc. · 199611cite it
  • K902859Servo Ventilator 300Siemens Life Support Systems · 199110cite it
  • K981072Esprit VentilatorRespironics, Inc. · 199810cite it
  • K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 200410cite it
  • K060647LTV 1200 VentilatorPulmonetic Systems, Inc. · 20069cite it
  • K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 20059cite it

Which CBK devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K252663Inbentus VersatileIconic Solutions by Murcia, SL · 202617generations
  • K201306Hamilton-C3Hamilton Medical AG · 202116generations
  • K201658Hamilton-C6Hamilton Medical AG · 202016generations
  • K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd. · 202415generations
  • K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC · 202415generations
  • K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC · 202015generations

What has FDA decided in CBK lately?

  • 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
  • K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2025

All 505 CBK decisions →

What has been recalled in CBK lately?

  • K162877VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.Ventec Life Systems, Inc. · Sep 17, 2026Class I
  • K162877V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number…Ventec Life Systems, Inc. · Sep 17, 2026Class I
  • K162877VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory…Ventec Life Systems, Inc. · Sep 17, 2026Class I
  • Z-0133-2027V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory…Ventec Life Systems, Inc. · Sep 17, 2026Class I
  • K162877VC (Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory…Ventec Life Systems, Inc. · Sep 17, 2026Class I
  • K162877VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for…Ventec Life Systems, Inc. · Sep 17, 2026Class I

Related product codes

Other codes under 21 CFR 868.5895.

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