510(k) Report

510(k) · Cleared

Recalled · Class I · 2013

Puritan-Bennett Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option, Model 840

K993071510(k) SpecialCleared Nov 24, 199971-day reviewClass II21 CFR 868.5895Recalls 1 (1 Class I)

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 Nov 24, 1999 as substantially equivalent to K902506 (Puritan Bennett Corp., 1991) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 1991. 1 of the 6 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided
Nov 24, 1999
Review
71 days
Class
Class II
Product code
CBK
Recalls
1 (1 Class I)
Predicates
2

Its longest line of descent runs back 2 generations to K902859 (1991). 5 ancestors in all, the oldest K902506 (1991). No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 1991: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestorK902859 · Servo Ventilator 300 · Siemens Life Support Systems · 1991 · recalledK961687 · EVITA 4 · Drager, Inc. · 1996199019921994199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors K961687 · EVITA 4 · Drager, Inc. · 1996K902859 · Servo Ventilator 300 · Siemens Life Support Systems · 1991 · recalled0
  1. Root · 2 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
  2. 1 generation backK961687 EVITA 4Drager, Inc. · 1996
  3. This deviceK993071 Puritan-Bennett Ventilator System with ET/Tracheostomy Tube…Puritan Bennett Corp. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K902859Servo Ventilator 300Siemens Life Support Systems19913
−1K961687EVITA 4Drager, Inc.1996—
0 (this device)K993071Puritan-Bennett Ventilator System with ET/Tracheostomy Tube Compensation, TC…Puritan Bennett Corp.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410
199510
FIG. 1 — Lineage of K993071, 1991–1999Source: 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), 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.

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? (2)

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
*K9025067200AE Microprocessor Ventilator W/Enhanced Hard.
Summary page 1
…racheostomy Tube. The 840 TC is substantially equivalent to the above mentioned predicate devices. Predicate Device 510(k) Number Classification Puritan-Bennett Corp. K902506B Class I, 7200 Series Ventilator Continuous Ventilator Per 21 CFR 868.5895 Drager K961687 Class Il, Evita 4 Ventilator Conti…
Puritan Bennett Corp.1991—
*K961687EVITA 4
Summary page 1
…vices. Predicate Device 510(k) Number Classification Puritan-Bennett Corp. K902506B Class I, 7200 Series Ventilator Continuous Ventilator Per 21 CFR 868.5895 Drager K961687 Class Il, Evita 4 Ventilator Continuous Ventilator Per 21 CFR 868.5895 020 I DEVICE DESCRIPTION The 840 Venti…
Drager, Inc.1996—

Also cleared against K902506: 6 other devices →

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 16, 2013Class IZ-0611-2014Software designCovidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • 6 other devices also cite its predicate K902506.

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)—

What is it indicated for?

The 840 Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K902506

6 other devices cite the same predicate.

  • K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 20021 Class I recall
  • K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 19981 Class I recall
  • K984379Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp. · 19984 recalls
  • K983112Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 19985 recalls
  • K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 19981 Class I recall
  • K964540Nellcor Puritan Bennett, 740 Ventilator SystemPuritan Bennett Corp. · 19974 recalls

More from Puritan Bennett Corp.

110 FDA decisions under this applicant name. See the company

  • K063650Ventilator with Respiratory Mechanics, Model 840Puritan Bennett Corp. · 2007
  • K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 20061 Class I recall
  • K023225Puritan Bennett Dataflow Data Management SoftwarePuritan Bennett Corp. · 2002
  • K022103Puritan-Bennett 700 Renaissance II Spirometry SystemPuritan Bennett Corp. · 2002
  • K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 20001 Class I recall

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/K993071 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993071: Puritan-Bennett Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option, Model 840.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993071

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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