510(k) · Cleared

Cleared

Oxygen Medicels, Citicels

K041773510(k) TraditionalCleared Jul 15, 200414-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

City Technology Limited · CCL Analyzer, Gas, Oxygen, Gaseous-Phase

Cleared on Jul 15, 2004 as substantially equivalent to K972992 (Ceramatec, Inc., 1998) after a 14-day review. Its family tree reaches back 2 generations to 1995.

Decided: Jul 15, 2004
Review: 14 days
Class: Class II
Product code: CCL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K953351 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK953351 Seatronics Family of Galvanic Oxygen SensorsSeatronics Co. · 1995
1 generation backK972992 Ceramatec Maxcell and Cag Galvanic Oxygen SensorsCeramatec, Inc. · 1998
This deviceK041773 Oxygen Medicels, CiticelsCity Technology Limited · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K953351	Seatronics Family of Galvanic Oxygen Sensors	Seatronics Co.	1995	—
−1	K972992	Ceramatec Maxcell and Cag Galvanic Oxygen Sensors	Ceramatec, Inc.	1998	—
0 (this device)	K041773	Oxygen Medicels, Citicels	City Technology Limited	2004	—

FIG. 1 — Lineage of K041773, 1995–2004Source: 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? (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
*	K972992	Ceramatec Maxcell and Cag Galvanic Oxygen Sensors Summary page 2 …y Marketed Predicate Device: The legally marketed predicate device is Ceramatec CAG-10 Oxygen Sensor. The predicate device was assigned 510(k) number K972992 and was declared substantially equivalent by FDA. Safety and Effectiveness: No differences in intended use o…	Ceramatec, Inc.	1998	—

Also cleared against K972992: 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 9 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K972992.

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 City Technology Medical replacement oxygen sensor is intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041773 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041773: Oxygen Medicels, Citicels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041773

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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