510(k) Report

510(k) · Cleared

Cleared

Uni-Vent (TM) Impact Minute Volume Ventilator

K870861510(k) TraditionalCleared Jan 19, 1988322-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

Impact Instrumentation, Inc. · CBK Ventilator, Continuous, Facility Use

Cleared on Jan 19, 1988 after a 322-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 10 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.

Decided
Jan 19, 1988
Review
322 days
Class
Class II
Product code
CBK
Recalls
None
Predicates
0

9 later devices descend from it, 2 citing it directly. 3 of the 10 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2004: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared, 1 with a Class I recall12013: 1 descendant cleared2017: 1 descendant cleared, 1 with a Class I recall12016: 1 descendant cleared, 1 with a Class I recall12024: 1 descendant cleared1990200020102020
  1. This deviceK870861 Uni-Vent (TM) Impact Minute Volume VentilatorImpact Instrumentation, Inc. · 1988
  2. Descendant · cites it directly · 8 of its ownK032386 Uni-Vent Model 730AEV (Automatic Emergency Ventilator)Impact Instrumentation, Inc. · 2004
  3. Descendant · cites it directly · 7 of its ownK071526 Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc. · 2008 · Recalled
  4. Descendant · 2 generations on · 6 of its ownK091238 Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 2009 · Recalled
  5. Descendant · 3 generations on · 5 of its ownK103318 Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2011 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK111473 Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · Recalled (Class I)

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2004: 12008: 12009: 12011: 12012: 12013: 12016: 12017: 12024: 1
2004high 1 (2004) · low 0 (2005)2026

Class I recalls in this family

  • K111473 Uni-Vent (R) Model 731 Series Portable Critical…4 generations on · 2012
  • K162832 731 Series Ventilators5 generations on · 2017
  • K153046 Hamilton-MR16 generations on · 2016

Most influential descendants

Showing 5 of 9 · See all
  • K032386Uni-Vent Model 730AEV (Automatic Emergency Ventilator)Impact Instrumentation, Inc. · 2004 · cites it directly8descendants
  • K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc. · 2008 · cites it directly7descendants
  • K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 2009 · 2 generations on6descendants
  • K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2011 · 3 generations on5descendants
  • K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870861Uni-Vent (TM) Impact Minute Volume VentilatorImpact Instrumentation, Inc.1988—
+1K032386Uni-Vent Model 730AEV (Automatic Emergency Ventilator)Impact Instrumentation, Inc.2004—
+1K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.20081
+2K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.20091
+3K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.20112
+4K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.2012Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200810
200910
201110
201211
201310
201611
201711
202410
FIG. 1 — Lineage of K870861, 1988–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

3 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
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? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032386Uni-Vent Model 730AEV (Automatic Emergency Ventilator)Impact Instrumentation, Inc.20048
K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.20087

Has anything in its family been recalled? (3 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.

  • K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
  • K153046Hamilton-MR1Hamilton Medical AG · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K032386 (Impact Instrumentation, Inc., 2004) has gone furthest, with 8 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 Impact Instrumentation, Inc.

27 FDA decisions under this applicant name. See the company

  • K133196Impact Model 323 AspiratorImpact Instrumentation, Inc. · 2014
  • K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 20121 Class I recall
  • K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc. · 20112 recalls
  • K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 20091 recall
  • K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc. · 20081 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/K870861 · printed Nov 6, 2026

Cite this page

510(k) Report. “K870861: Uni-Vent (TM) Impact Minute Volume Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870861

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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