510(k) Report

510(k) · Cleared

Recalled · Class I · 2024

VDR Sinusoidal Percusionator Family/Relate Access

K905235510(k) TraditionalCleared May 3, 1991177-day reviewClass II21 CFR 868.5895Recalls 3 (2 Class I)

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

Percussionaire Corp. · CBK Ventilator, Continuous, Facility Use

Cleared on May 3, 1991 after a 177-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has a Class I recall. It has been recalled 3 times, including 2 Class I recalls.

Decided
May 3, 1991
Review
177 days
Class
Class II
Product code
CBK
Recalls
3 (2 Class I)
Predicates
0

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

FIG. 1 — Lineage of K905235Source: FDA 510(k) database · 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.

1 device in this family has 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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 23, 2024Class IZ-0960-2025Process controlDue to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
Mar 28, 2023Class IZ-0693-2024Process controlBreathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
Sep 14, 2020Class IIZ-0259-2024Device DesignNote this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware.

No ancestor or descendant has a Class I recall.

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 Percussionaire Corp.

11 FDA decisions under this applicant name. See the company

  • K905234TXP Transporter Family and Related AccessoriesPercussionaire Corp. · 19911 Class I recall
  • K905236Ipv Percussionator Family & Related AccessoriesPercussionaire Corp. · 19911 Class I recall
  • K900315Percussionaire TXP Transporter/Respirators 750 MinPercussionaire Corp. · 1990
  • K900313Percussionaire (R) VDR-3 Imv Percus/Respir 1250 MinPercussionaire Corp. · 1990
  • K900314Percussionaire (R) Oscillatron-1 Percuss 1300 MinPercussionaire Corp. · 1990

Recent decisions in CBK

The CBK category page

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https://510kreport.com/device/K905235 · printed Nov 6, 2026

Cite this page

510(k) Report. “K905235: VDR Sinusoidal Percusionator Family/Relate Access.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905235

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