510(k) · Cleared

Cleared

Tenacore Oxygen Blender, Model TB-2000

K081335510(k) TraditionalCleared Nov 14, 2008186-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

Tenacore Holdings, Inc. · BZR Mixer, Breathing Gases, Anesthesia Inhalation

Cleared on Nov 14, 2008 as substantially equivalent to K925982 (Biomedical Devices, Inc., 1993) after a 186-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Nov 14, 2008
Review: 186 days
Class: Class II
Product code: BZR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K925982 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK925982 BMD Air/Oxygen BlenderBiomedical Devices, Inc. · 1993
This deviceK081335 Tenacore Oxygen Blender, Model TB-2000Tenacore Holdings, Inc. · 2008
Descendant · cites it directly · 0 of its ownK113232 Maxmixing BlockMaxtec, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all

K113232Maxmixing BlockMaxtec, Inc. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925982	BMD Air/Oxygen Blender	Biomedical Devices, Inc.	1993	—
0 (this device)	K081335	Tenacore Oxygen Blender, Model TB-2000	Tenacore Holdings, Inc.	2008	—
+1	K113232	Maxmixing Block	Maxtec, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K081335, 1993–2012Source: 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? (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
*	K925982	BMD Air/Oxygen Blender Summary page 1 …Contact Brand Caso, QA Director Ph: 714-444-4643 Fx: 714-549-7835 Date Prepared May 1, 2008 Product Name Tenacore Oxygen Blender Predicate Device K925982 Product Description The Tenacore Oxygen Blender is typically a wall-mounted unit that provides inlets for medical grade air and…	Biomedical Devices, Inc.	1993	—

Also cleared against K925982: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K113232	Maxmixing Block	Maxtec, Inc.	2012	0

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?

Its one ancestor has no recall.
Of its descendants, K113232 (Maxtec, Inc., 2012) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K925982.

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. 2008, 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 Tenacore Oxygen Blender, is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081335 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081335: Tenacore Oxygen Blender, Model TB-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081335

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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