510(k) · Cleared
ClearedBear Cub 750 PSV
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 Sep 16, 1999 as substantially equivalent to K970839 (Siemens Elema AB, 1997) and 2 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1991. 41 of the 141 devices in its family, counting itself, have a Class I recall. 134 later devices descend from it.
- Decided
- Sep 16, 1999
- Review
- 28 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K902859 (1991). 6 ancestors in all, the oldest K895541 (1990). 134 later devices descend from it, 1 citing it directly. 41 of the 141 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 2 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 1 generation backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- This deviceK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 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 |
|---|---|---|---|---|---|
| −3 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −2 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −1 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| 0 (this device) | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| +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 |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K970839 | Servo Ventilator 300ASummary page 1…REGISTRATION NUMBER: 2022747 3. PRODUCT CLASSIFICATION Class I 4. ANESTHESIOLOGY DEVICE CLASSIFICATION PANEL (73 CBK) Predict Device Siemens Servo 300 A Ventilator (K970839) V.LP. Bird Ventilator (K895541) Baby Log 8000 Plus Ventilator (K974176) Device Description The BEAR CUB 750 PSV Infant ventila… | 1997 |
| * | K895541 | V.I.P. Bird Infant - Pediatric VentilatorSummary page 1…. PRODUCT CLASSIFICATION Class I 4. ANESTHESIOLOGY DEVICE CLASSIFICATION PANEL (73 CBK) Predict Device Siemens Servo 300 A Ventilator (K970839) V.LP. Bird Ventilator (K895541) Baby Log 8000 Plus Ventilator (K974176) Device Description The BEAR CUB 750 PSV Infant ventilators is a modification from the… | 1990 |
| * | K974176 | Babylog 8000 PlusSummary page 1…STHESIOLOGY DEVICE CLASSIFICATION PANEL (73 CBK) Predict Device Siemens Servo 300 A Ventilator (K970839) V.LP. Bird Ventilator (K895541) Baby Log 8000 Plus Ventilator (K974176) Device Description The BEAR CUB 750 PSV Infant ventilators is a modification from the BEAR CUB 750 vs. The BEAR CUB 750 PSV In… | 1998 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K013642 (Bird Products Corp., 2002) has gone furthest, with 133 descendants of its own.
- 7 other devices also cite its predicate K970839.
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 CUB 750 PSV Infant Ventilator is intended to provide ventilatory support for a patient
population ranging from the small neonate 500 grams and larger to a small pediatric patient up to 30
kilograms.
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/K992788 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992788: Bear Cub 750 PSV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992788
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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