510(k) · Cleared

Cleared

Maxmixing Block

K113232510(k) TraditionalCleared Mar 1, 2012120-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

Maxtec, Inc. · BZR Mixer, Breathing Gases, Anesthesia Inhalation

Cleared on Mar 1, 2012 as substantially equivalent to K884973 (Key Instruments, 1989) and 3 other predicates after a 120-day review. Its family tree reaches back 2 generations to 1988.

Decided: Mar 1, 2012
Review: 120 days
Class: Class II
Product code: BZR
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K883038 (1988). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK883038 P/N 9320 Low Flow Air/Oxygen MicroblenderBird Products Corp. · 1988
1 generation backK973646 Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerBird Products Corp. · 1998
This deviceK113232 Maxmixing BlockMaxtec, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K883038	P/N 9320 Low Flow Air/Oxygen Microblender	Bird Products Corp.	1988	—
−1	K973646	Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer	Bird Products Corp.	1998	—
0 (this device)	K113232	Maxmixing Block	Maxtec, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	2	0
1993	1	0
2006	1	0
2008	1	0

FIG. 1 — Lineage of K113232, 1988–2012Source: 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.

Planning a device in BZR? 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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K884973	FR6000 Flowmeter Summary page 1 …esiology 3) The following predicate devices were used to establish substantial equivalence for the MaxMixing Block/Analyzer System: * 510(k) K884973 -FR6000 Flowmeter * 5 10(k) K053232 - Precision Air Oxygen Blender a 510(k) K081335 - Tenacore Ox…	Key Instruments	1989	—
*	K053232	Precision Blender Summary page 1 …e used to establish substantial equivalence for the MaxMixing Block/Analyzer System: * 510(k) K884973 -FR6000 Flowmeter * 5 10(k) K053232 - Precision Air Oxygen Blender a 510(k) K081335 - Tenacore Oxygen Blender * 510(k) K973646 -Bird…	Precision Medical, Inc.	2006	—
*	K081335	Tenacore Oxygen Blender, Model TB-2000 Summary page 1 …xing Block/Analyzer System: * 510(k) K884973 -FR6000 Flowmeter * 5 10(k) K053232 - Precision Air Oxygen Blender a 510(k) K081335 - Tenacore Oxygen Blender * 510(k) K973646 -Bird Sentry Blender 6526 South Cottonwood Street * Satt Lake City…	Tenacore Holdings, Inc.	2008	—
*	K973646	Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer Summary page 1 …73 -FR6000 Flowmeter * 5 10(k) K053232 - Precision Air Oxygen Blender a 510(k) K081335 - Tenacore Oxygen Blender * 510(k) K973646 -Bird Sentry Blender 6526 South Cottonwood Street * Satt Lake City, Utah 84107 owww.maxtecinlc.com *866.4.maxtec…	Bird Products Corp.	1998	—

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?

The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 13.8 years on median.
None of the 8 ancestors has a recall.

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. 2012, this device’s year, is highlighted.

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 MaxMixing Block, a breathing gas mixer designed to provide intermittent or continuous controlled flows of an air/oxygen gas mixture to infant, pediatric, and adult patients. The MaxMixing Block is intended to be used with a Maxtec Oxygen Analyzer. The MaxMixing Block 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 as stated in the FDA summary.

https://510kreport.com/device/K113232 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113232: Maxmixing Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113232

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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