510(k) · Cleared
ClearedBird Monitor Interface
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 Oct 22, 1998 as substantially equivalent to K880721 (Bird Products Corp., 1988) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Oct 22, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K841757 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK841757 7200 Microprocessor VentilatorPuritan Bennett Corp. · 1984
- This deviceK982580 Bird Monitor InterfaceBird Products Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841757 | 7200 Microprocessor Ventilator | Puritan Bennett Corp. | 1984 | — |
| 0 (this device) | K982580 | Bird Monitor Interface | Bird Products Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 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.
Planning a device in CBK? 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? (2)
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 |
|---|---|---|---|
| * | K880721 | 6400ST Interface Module-RS232Summary page 2…ccessory to Bird Products Corporation ventilator products classified under 73 CBK “Continuous Ventilators” Predicate Device: Bird RS-232 Interface Module FDA 510(k) No: K880721 Option 20-26 of Puritan Bennett 7200 Volume Ventilator FDA 510(k) No: K841757 Intended Use: The Bird Monitor Interface (BMI) i… | 1988 |
| * | K841757 | 7200 Microprocessor VentilatorSummary page 2…BK “Continuous Ventilators” Predicate Device: Bird RS-232 Interface Module FDA 510(k) No: K880721 Option 20-26 of Puritan Bennett 7200 Volume Ventilator FDA 510(k) No: K841757 Intended Use: The Bird Monitor Interface (BMI) is a stand-alone unit providing a means of communicating information from Bird v… | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
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 Bird Monitor Interface (BMI) is a stand-alone unit providing a means of communicating information from Bird ventilators to patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin and SpaceLabs PDMS are provided, as well as a Bird proprietary interface for use with other systems. The purpose of BMI is to deliver ventilator settings, monitored values, alarm information and waveform data to the patient monitoring system.
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/K982580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982580: Bird Monitor Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982580
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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