510(k) · Cleared

Cleared

Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer

K973646510(k) TraditionalCleared May 7, 1998225-day reviewClass II21 CFR 868.5330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bird Products Corp. · BZR Mixer, Breathing Gases, Anesthesia Inhalation

Cleared on May 7, 1998 as substantially equivalent to K911962 (Bird Products Corp., 1991) and 2 other predicates after a 225-day review. Its family tree reaches back 1 generation to 1988. 38 of the 129 devices in its family, counting itself, have a Class I recall. 125 later devices descend from it.

Decided: May 7, 1998
Review: 225 days
Class: Class II
Product code: BZR
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K883038 (1988). 3 ancestors in all. 125 later devices descend from it, 3 citing it directly. 38 of the 129 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK883038 P/N 9320 Low Flow Air/Oxygen MicroblenderBird Products Corp. · 1988
This deviceK973646 Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerBird Products Corp. · 1998
Descendant · cites it directly · 120 of its ownK020746 Bird Tbird Vela VentilatorBird Products Corp. · 2002
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 125 descendants. See all descendants

Descendants cleared per year

2002high 14 (2012) · low 0 (2003)2026

Class I recalls in this family

K070594 Palmtop Ventilator, Models PTV-8, PTV-103 generations on · 2007
K090888 Newport HT70 Family of Ventilators4 generations on · 2009
K093261 MOVES4 generations on · 2010
K162877 VOCSN Unified Respiratory System4 generations on · 2017

Most influential descendants

Showing 5 of 125 · See all

K020746Bird Tbird Vela VentilatorBird Products Corp. · 2002 · cites it directly120descendants
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	K883038	P/N 9320 Low Flow Air/Oxygen Microblender	Bird Products Corp.	1988	—
0 (this device)	K973646	Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer	Bird Products Corp.	1998	—
+1	K020746	Bird Tbird Vela Ventilator	Bird Products Corp.	2002	—
+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
1991	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	2	0
2005	1	0
2006	3	0
2007	2	1
2008	6	1
2009	5	1
2010	3	1
2011	12	7
2012	14	5
2013	10	4
2014	5	1
2015	7	1
2016	7	2
2017	10	4
2018	2	0
2019	7	3
2020	4	3
2021	6	3
2022	1	0
2023	3	1
2024	5	0
2025	4	0
2026	5	0

FIG. 1 — Lineage of K973646, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

38 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 BZR device

#1 K243917 F&P Optiflow Air/Oxygen Flow Sourcescore 12.1 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K911962	Bird Sentry Air/Oxygen Microblender Summary page 2 …ases, Anesthesia Inhalation, 73 BZR -and - e 868.1720 Analyzer, Gas, Oxygen, Gaseous Phase, 73 CCL Predicate Device: Bird Sentry Air/Oxygen Microblender FDA 510(k) No: K911962A Ceramatec OM25E Oxygen Analyzer FDA 510(k) No: K911344A Bird Low Flow Air/Oxygen Blender FDA 510(k) No: K883038 Intended Use:…	Bird Products Corp.	1991	—
*	K911344	Cerion Hand Held Oxygen Analyzer Summary page 2 …alyzer, Gas, Oxygen, Gaseous Phase, 73 CCL Predicate Device: Bird Sentry Air/Oxygen Microblender FDA 510(k) No: K911962A Ceramatec OM25E Oxygen Analyzer FDA 510(k) No: K911344A Bird Low Flow Air/Oxygen Blender FDA 510(k) No: K883038 Intended Use: The modified Bird Sentry™ Blender is designed to provid…	Ceramatec, Inc.	1991	—
*	K883038	P/N 9320 Low Flow Air/Oxygen Microblender Summary page 2 …ce: Bird Sentry Air/Oxygen Microblender FDA 510(k) No: K911962A Ceramatec OM25E Oxygen Analyzer FDA 510(k) No: K911344A Bird Low Flow Air/Oxygen Blender FDA 510(k) No: K883038 Intended Use: The modified Bird Sentry™ Blender is designed to provide a continuous air/oxygen gas mixture to infant, pediatric…	Bird Products Corp.	1988	—

Also cleared against K911962: 2 other devices →

What descends from it? (125)

See all 125

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020746	Bird Tbird Vela Ventilator	Bird Products Corp.	2002	120
K161718	MaxBlend 2, MaxBlend Lite	Maxtec, LLC	2016	2
K113232	Maxmixing Block	Maxtec, Inc.	2012	0

Has anything in its family been recalled? (38 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.

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
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
K121225Hamilton-C2Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
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
K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
K120670Hamilton-T1Hamilton Medical AG · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls

Nearest 12 of 38 shown.

Nearest 5 of 38; all are on the web page.

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K020746 (Bird Products Corp., 2002) has gone furthest, with 120 descendants of its own.
2 other devices also cite its predicate K911962.

How does its category compare?

All BZR devices

BZR Mixer, Breathing Gases, Anesthesia Inhalation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZR

1in 2025

2007high 4 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZR

203in 2023

2007high 203 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZR

No recall names BZR since 2007.

Adverse event reports per year · BZR

13in 2025

2007high 39 (2015) · low 4 (2009)2025

MAUDE reports naming product code BZR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	15
2008	1	—	20
2009	1	—	4
2010	1	—	22
2011	2	—	11
2012	2	—	27
2013	0	—	18
2014	0	—	11
2015	1	—	39
2016	1	—	30
2017	0	—	22
2018	1	—	24
2019	0	—	26
2020	0	—	15
2021	1	—	33
2022	0	—	15
2023	4	203	19
2024	1	—	18
2025	1	—	13
2026	0	—	—

What is it indicated for?

The modified Bird Sentry™ Blender is designed to provide a continuous air/oxygen gas mixture to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician in institutional environments where delivery and monitoring of air/oxygen mixtures is required.

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/K973646 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973646: Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973646

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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