510(k) · Cleared

Cleared

GMX Series Medical Air/Oxygen Blender

K142291510(k) TraditionalCleared May 19, 2015274-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

Gentec (Shanghai) Corporation · BZR Mixer, Breathing Gases, Anesthesia Inhalation

Cleared on May 19, 2015 as substantially equivalent to K053232 (Precision Medical, Inc., 2006) after a 274-day review. Its family tree reaches back 2 generations to 1993.

Decided: May 19, 2015
Review: 274 days
Class: Class II
Product code: BZR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K925982 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK925982 BMD Air/Oxygen BlenderBiomedical Devices, Inc. · 1993
1 generation backK053232 Precision BlenderPrecision Medical, Inc. · 2006
This deviceK142291 GMX Series Medical Air/Oxygen BlenderGentec (Shanghai) Corporation · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K925982	BMD Air/Oxygen Blender	Biomedical Devices, Inc.	1993	—
−1	K053232	Precision Blender	Precision Medical, Inc.	2006	—
0 (this device)	K142291	GMX Series Medical Air/Oxygen Blender	Gentec (Shanghai) Corporation	2015	—

FIG. 1 — Lineage of K142291, 1993–2015Source: 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? (1)

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
*	K053232	Precision Blender Summary page 4 …lender Classification Name: breathing gas mixer CFR 868.5330 Product Code: BZR Predicate Device(s): Precision Blender (K053232) The GMX Series Medical Air/Oxygen blender is a restricted Device Description:…	Precision Medical, Inc.	2006	—

Also cleared against K053232: 5 other devices →

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 22 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
None of the 2 ancestors has a recall.
5 other devices also cite its predicate K053232.

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. 2015, 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 GMX Series Medical Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142291 · printed Nov 5, 2026

Cite this page

510(k) Report. “K142291: GMX Series Medical Air/Oxygen Blender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142291

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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