510(k) · Cleared

Cleared

Model 02 Oxygen Analyzer

K971084510(k) TraditionalCleared Jul 21, 1998483-day reviewClass II21 CFR 868.1720

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

Oxigraf, Inc. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase

Cleared on Jul 21, 1998 as substantially equivalent to K961644 (Minesafety Appliances Co., 1996) and 1 other predicate after a 483-day review. Its family tree reaches back 2 generations to 1983.

Decided: Jul 21, 1998
Review: 483 days
Class: Class II
Product code: CCL
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K833326 (1983). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK833326 Mini OX Iii Oxygen MonitorCatalyst Research Corp. · 1983
1 generation backK961644 Miniox 3000 Oxygen MonitorMinesafety Appliances Co. · 1996
This deviceK971084 Model 02 Oxygen AnalyzerOxigraf, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K833326	Mini OX Iii Oxygen Monitor	Catalyst Research Corp.	1983	—
−1	K961644	Miniox 3000 Oxygen Monitor	Minesafety Appliances Co.	1996	—
0 (this device)	K971084	Model 02 Oxygen Analyzer	Oxigraf, Inc.	1998	—

FIG. 1 — Lineage of K971084, 1983–1998Source: 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 CCL? 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 CCL device

#1 K261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)score 12.7 · 4 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? (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	Applicant	Decided	Recalls
*	K961644	Miniox 3000 Oxygen Monitor Summary page 1 …xygen Monitor, Oxygen Sensor CLASSIFICATION NAME: Oxygen gas analyzer (868.1720Q) MARKETED PREDICATE DEVICE: MiniOx 3000 Oxygen Monitor Mine Safety Appliances Company K961644, K833326 SUMMARY DATE: March 9, 1998 CONTACT: Bruce W. McCaul, President The Mode!l 02 Oxygen Analyzer measures and displays ox…	Minesafety Appliances Co.	1996	—
*	K833326	Mini OX Iii Oxygen Monitor Summary page 1 …itor, Oxygen Sensor CLASSIFICATION NAME: Oxygen gas analyzer (868.1720Q) MARKETED PREDICATE DEVICE: MiniOx 3000 Oxygen Monitor Mine Safety Appliances Company K961644, K833326 SUMMARY DATE: March 9, 1998 CONTACT: Bruce W. McCaul, President The Mode!l 02 Oxygen Analyzer measures and displays oxygen conc…	Catalyst Research Corp.	1983	—

Also cleared against K961644: 1 other device →

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 15 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K961644.

How does its category compare?

All CCL devices

CCL Analyzer, Gas, Oxygen, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCL

2in 2025

2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCL

Too few CCL 510(k)s in any year since 2007 to give a median.

Recalls per year · CCL

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CCL

2in 2025

2007high 8 (2014) · low 0 (2022)2025

MAUDE reports naming product code CCL, 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	2	—	0	1
2008	2	—	0	2
2009	0	—	1	2
2010	0	—	0	5
2011	1	—	0	4
2012	0	—	0	5
2013	2	—	0	3
2014	0	—	0	8
2015	0	—	0	5
2016	1	—	0	1
2017	0	—	0	2
2018	1	—	0	1
2019	0	—	0	1
2020	0	—	0	1
2021	0	—	0	3
2022	2	—	0	0
2023	1	—	0	4
2024	0	—	0	4
2025	2	—	0	2
2026	1	—	0	—

What is it indicated for?

The Model 02 is intended to provide continuous, direct patient monitoring of oxygen mixtures in a wide variety of medical applications such as anesthesiology (e.g., anesthesia and breathing machines), respiratory therapy (e.g., breathing circuits, respirators, ventilators and pediatric incubators), and oxygen therapy (e.g., oxygen concentrators, tents, masks and nasal cannulas). The Model 02 is designed to be used by trained health care professionals under the supervision of a physician in a hospital, clinic, or emergency medicine setting.

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/K971084 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971084: Model 02 Oxygen Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971084

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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