510(k) · Cleared
ClearedBear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore CP-100, HI-LO Jet ET Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bear Medical Systems, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Nov 20, 1998 as substantially equivalent to K912619 (Bear Medical Systems, Inc., 1992) and 2 other predicates after an 11-day review. Its family tree reaches back 1 generation to 1990. 41 of the 138 devices in its family, counting itself, have a Class I recall. 134 later devices descend from it.
- Decided
- Nov 20, 1998
- Review
- 11 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K900696 (1990). 3 ancestors in all. 134 later devices descend from it, 1 citing it directly. 41 of the 138 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK900696 Biore CP-100 Cardiopulmonary MonitorBicore Monitoring Systems · 1990
- This deviceK983981 Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore…Bear Medical Systems, Inc. · 1998
- Descendant · cites it directly · 133 of its ownK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 3 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 3 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- Descendant · 4 generations on · 86 of its ownK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
Showing 5 of 134 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 134 · See all- K013642AVEABird Products Corp. · 2002 · cites it directly133descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 2 generations on114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 3 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 3 generations on87descendants
- K061627Modification to I Vent 201Versamed Medical Systems, Inc. · 2006 · 4 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900696 | Biore CP-100 Cardiopulmonary Monitor | Bicore Monitoring Systems | 1990 | — |
| 0 (this device) | K983981 | Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore CP-100, HI-LO… | Bear Medical Systems, Inc. | 1998 | — |
| +1 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| +2 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +3 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +3 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +4 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 1 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 1 |
| 2008 | 8 | 1 |
| 2009 | 5 | 1 |
| 2010 | 5 | 1 |
| 2011 | 12 | 7 |
| 2012 | 11 | 4 |
| 2013 | 10 | 4 |
| 2014 | 6 | 1 |
| 2015 | 8 | 1 |
| 2016 | 8 | 3 |
| 2017 | 11 | 5 |
| 2018 | 3 | 1 |
| 2019 | 7 | 3 |
| 2020 | 4 | 3 |
| 2021 | 7 | 3 |
| 2022 | 1 | 0 |
| 2023 | 2 | 1 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 0 |
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.
41 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 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K912619 | Bear 7 VentilatorSummary page 2…rator) ESTABLISHMENT REGISTRATION NUMBER: 2022747 PRODUCT CLASSIFICATION Class IT ANESTHESIOLOGY DEVICE CLASSIFICATION PANEL (73 CBK) Comparison to Predicate Device; k912619/A BEAR 1000® Ventilator k901448 Hamilton Veolar, with Leonardo Graphics k935788 SMARTCATH INTRATRACHEAL CATHETER now known as t… | 1992 |
| * | K935788 | Bicore Smartcath Intratracheal CatheterSummary page 2…T ANESTHESIOLOGY DEVICE CLASSIFICATION PANEL (73 CBK) Comparison to Predicate Device; k912619/A BEAR 1000® Ventilator k901448 Hamilton Veolar, with Leonardo Graphics k935788 SMARTCATH INTRATRACHEAL CATHETER now known as the BICORE CP 2000 k900696B CP-100 Pulmonary Monitor 510k Summary… | 1995 |
| * | K900696 | Biore CP-100 Cardiopulmonary MonitorSummary page 2…icate Device; k912619/A BEAR 1000® Ventilator k901448 Hamilton Veolar, with Leonardo Graphics k935788 SMARTCATH INTRATRACHEAL CATHETER now known as the BICORE CP 2000 k900696B CP-100 Pulmonary Monitor 510k Summary as required by section 807.92 page 3 of 11 Statement of Indication for U… | 1990 |
| † | K901448 | Veolar Ventilator | 1991 |
What descends from it? (134)
See all 1341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013642 | AVEA Class I | 2002 | 133 |
Has anything in its family been recalled? (41 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.
- K013642AVEABird Products Corp. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 113 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 5 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K103211Avea VentilatorCare Fusion · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
Nearest 12 of 41 shown.
Nearest 5 of 41; all are on the web page.
What does this lineage say?
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The BEAR® 1000 Ventilator is fully capable of ventilating the entire spectrum of patients requiring such support-from the Emergency Room to the ICU, from pediatric patients to adults. The BEAR® 1000 Ventilator is available in a standard model as well as an upgraded model which includes the fully loaded enhancement package. The standard model BEAR™ 1000 Ventilator offers the clinician the following ventilatory modes: - Assist CMV - STMV (with or without…
Read the full statement (111 words)
The BEAR® 1000 Ventilator is fully capable of ventilating the entire spectrum of patients requiring such support-from the Emergency Room to the ICU, from pediatric patients to adults.
The BEAR® 1000 Ventilator is available in a standard model as well as an upgraded model which includes the fully loaded enhancement package. The standard model BEAR™ 1000 Ventilator offers the clinician the following ventilatory modes:
- Assist CMV
- STMV (with or without Pressure Support), and
- CPAP (with or without Pressure Support)
In addition the Enhancement Package offers additional functions such as:
- Pressure Control Ventilation
- Minimum Minute Volume capability
- Pressure Augmentation
- Smart Trigger
- ES (Esophageal Monitoring)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983981 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983981: Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore CP-100, HI-LO Jet ET Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983981
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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