510(k) Report

510(k) · Cleared

Recalled · Class I · 2023

Bellavista

K183364510(k) TraditionalCleared Sep 13, 2019283-day reviewClass II21 CFR 868.5895Recalls 3 (1 Class I)

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

Imtmedical AG · CBK Ventilator, Continuous, Facility Use

Cleared on Sep 13, 2019 as substantially equivalent to K163127 (Imtmedical AG, 2017) after a 283-day review. Its family tree reaches back 1 generation to 2017. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled 3 times, including a Class I recall.

Decided
Sep 13, 2019
Review
283 days
Class
Class II
Product code
CBK
Recalls
3 (1 Class I)
Predicates
1

Its longest line of descent runs back 1 generation to K163127 (2017). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.

Reference device: K161450 · Hamilton-C3 · Hamilton Medical AG · 2017 · recalledReference device: K093633 · Infinity Acute Care System Workstation Critical Care · Draegerwerk AG & CO Kgaa · 2010 · Class I recallReference device: K103211 · Avea Ventilator · Care Fusion · 2011 · Class I recallReference device: K070594 · Palmtop Ventilator, Models PTV-8, PTV-10 · Pulmonetic Systems, Inc. · 2007 · Class I recallReference device: K031745 · Infant Flow Plus Infant Cpap System with Sipap Function · Sensor Medics Corp. · 2004Reference device: K151814 · SERVO-U Ventilator System, SERVO-n Ventilator System · Maquet Critical Care AB · 2015Reference device: K151252 · Puritan Bennett 840 Series Ventilator System · Covidien LP · 2016K163127 · bellavista 1000 · Imtmedical AG · 2017 · recalled201620182020
K163127 · bellavista 1000 · Imtmedical AG · 2017 · recalled0
  1. Root · 1 generation backK163127 bellavista 1000Imtmedical AG · 2017 · Recalled
  2. This deviceK183364 BellavistaImtmedical AG · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K163127bellavista 1000Imtmedical AG20171
0 (this device)K183364BellavistaImtmedical AG2019—
FIG. 1 — Lineage of K183364, 2017–2019Source: 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? (1)

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
*K163127bellavista 1000
Summary page 4
…use Product Code: CBK Regulatory Class: Class II Predicate Device: bellavista 1000 (K163127) Vyaire Medical, Inc. Vyaire Medical, Inc. Vyaire Medical Oy Vyaire Medical GmbH…
Imtmedical AG20171
†K161450Hamilton-C3Hamilton Medical AG20172
†K093633Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa2010Class I
†K103211Avea VentilatorCare Fusion2011Class I
†K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc.2007Class I
†K031745Infant Flow Plus Infant Cpap System with Sipap FunctionSensor Medics Corp.2004—
†K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB2015—
†K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP2016—

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
May 5, 2023Class IIZ-1966-2023Nonconforming Material/ComponentVyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP…
May 5, 2023Class IIZ-1967-2023Nonconforming Material/ComponentVyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP…
Dec 20, 2021Class IZ-0622-2022Software change controlPotential cessation in ventilation can occur under specific conditions.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a 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. 2019, this device’s year, is highlighted.

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 bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients and optionally infant and neonatal patients by qualified, trained personnel under the direction of a physician.

Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer

When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).

Indications for use as stated in the FDA summary.

More from Imtmedical AG

2 FDA decisions under this applicant name. See the company

  • K163127bellavista 1000Imtmedical AG · 20171 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/K183364 · printed Nov 4, 2026

Cite this page

510(k) Report. “K183364: Bellavista.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183364

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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