510(k) · Cleared
ClearedBicore Smartcath Intratracheal Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bicore Monitoring Systems · MOD Accessory To Continuous Ventilator (Respirator)
Cleared on Jul 3, 1995 after a 574-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 41 of the 136 devices in its family, counting itself, have a Class I recall. 135 later devices descend from it.
- Decided
- Jul 3, 1995
- Review
- 574 days
- Class
- Class II
- Product code
- MOD
- Recalls
- None
- Predicates
- 0
135 later devices descend from it, 2 citing it directly. 41 of the 136 devices in this family, counting this one, have a Class I recall.
- This deviceK935788 Bicore Smartcath Intratracheal CatheterBicore Monitoring Systems · 1995
- Descendant · cites it directly · 134 of its ownK983981 Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore…Bear Medical Systems, Inc. · 1998
- Descendant · 2 generations on · 133 of its ownK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- Descendant · 3 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 4 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 4 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 135 · See all- K983981Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore CP-100, HI-LO Jet ET TubeBear Medical Systems, Inc. · 1998 · cites it directly134descendants
- K013642AVEABird Products Corp. · 2002 · 2 generations on133descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 3 generations on114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 4 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935788 | Bicore Smartcath Intratracheal Catheter | Bicore Monitoring Systems | 1995 | — |
| +1 | K983981 | Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore CP-100, HI-LO… | Bear Medical Systems, Inc. | 1998 | — |
| +2 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| +3 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +4 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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), 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 MOD device
- #1 K261360 EasyCare Tx 2score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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? (135)
See all 1352 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 113 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 5 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 5 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 · 6 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K103211Avea VentilatorCare Fusion · 2011 · 6 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?
- Of its descendants, K983981 (Bear Medical Systems, Inc., 1998) has gone furthest, with 134 descendants of its own.
How does its category compare?
All MOD devicesMOD Accessory To Continuous Ventilator (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOD
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOD
125in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOD
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOD
1in 2022
MAUDE reports naming product code MOD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 125 | 1 | — |
https://510kreport.com/device/K935788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935788: Bicore Smartcath Intratracheal Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935788
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026