510(k) · Cleared
Recalled · 2006Bird V.I.P. Gold/Sterling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bird Products Corp. · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 20, 1999 as substantially equivalent to K970839 (Siemens Elema AB, 1997) and 2 other predicates after a 69-day review. Its family tree reaches back 3 generations to 1991. 41 of the 140 devices in its family, counting itself, have a Class I recall. 134 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 20, 1999
- Review
- 69 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 3 generations to K902859 (1991). 5 ancestors in all, the oldest K901885 (1990). 134 later devices descend from it, 1 citing it directly. 41 of the 140 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 deviceK993449 Bird V.I.P. Gold/SterlingBird Products Corp. · 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) | K993449 | Bird V.I.P. Gold/Sterling | Bird Products Corp. | 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 |
| 1992 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K930474 | FDA’s K930474 is Needle, Pneumoperitoneum, Spring Loaded Our OCR of the scanned summary read K930474, FDA’s number for Needle, Pneumoperitoneum, Spring Loaded (Ranfac, Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Bird 8400Sti”. Kept off the family tree. Summary page 1…atric Ventilator 2. ESTABLISHMENT REGISTRATION NUMBER: 2021710 3 PRODUCT CLASSIFICATION Class II 4. ANESTHESIOLOGY DEVICE CLASSIFICATION PANEL(73 CBK) Bird 8400Sti (K930474) Bird Products Corporation Siemens Servo 300 A Ventilator (K970839) Siemens Bird Partner Volume Monitor (K901885) (K915488)… | 1993 |
| * | K970839 | Servo Ventilator 300ASummary page 1…ODUCT CLASSIFICATION Class II 4. ANESTHESIOLOGY DEVICE CLASSIFICATION PANEL(73 CBK) Bird 8400Sti (K930474) Bird Products Corporation Siemens Servo 300 A Ventilator (K970839) Siemens Bird Partner Volume Monitor (K901885) (K915488) Bird Products Corporation The additions to the ventilator will be: T… | 1997 |
| * | K901885 | Partner Volume MonitorSummary page 1…Y DEVICE CLASSIFICATION PANEL(73 CBK) Bird 8400Sti (K930474) Bird Products Corporation Siemens Servo 300 A Ventilator (K970839) Siemens Bird Partner Volume Monitor (K901885) (K915488) Bird Products Corporation The additions to the ventilator will be: The addition of Pressure Control mode of ventilat… | 1990 |
| * | K915488 | Pediatric Ventilator and Partner Volume MonitorSummary page 1…LASSIFICATION PANEL(73 CBK) Bird 8400Sti (K930474) Bird Products Corporation Siemens Servo 300 A Ventilator (K970839) Siemens Bird Partner Volume Monitor (K901885) (K915488) Bird Products Corporation The additions to the ventilator will be: The addition of Pressure Control mode of ventilation with V… | 1992 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2006 | Not classified | Z-0480-2007 | Other | The reason for this correction is due to the potential of a repeat ''failure to cycle'' event. |
| Oct 20, 2006 | Not classified | Z-0481-2007 | Other | The reason for this correction is due to the potential of a repeat ''failure to cycle'' event. |
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 2.2 years on median.
- 2 of the 5 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 VIP Bird Gold and VIP Sterling are ventilators intended to treat respiratory failure or respiratory insufficiency, in neonatal, infant and pediatric patients. The ventilators are intended for institutional use only, and not for emergency medical transport or home use.
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/K993449 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993449: Bird V.I.P. Gold/Sterling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993449
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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