510(k) · Cleared

Cleared

Datex-Ohmeda S/5 Tonometry Module, E Tono and Accessories

K052167510(k) SpecialCleared Sep 8, 200530-day reviewClass II21 CFR 868.1400

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

GE Healthcare · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Sep 8, 2005 as substantially equivalent to K993656 (Datex-Ohmeda, Inc., 2000) after a 30-day review. Its family tree reaches back 2 generations to 1997.

Decided: Sep 8, 2005
Review: 30 days
Class: Class II
Product code: CCK
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K962638 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK962638 Tonocap, TC-200 and Accessory CathetersInstrumentarium Corp. · 1997
1 generation backK993656 Datex-Ohmeda Tonometry Module M-TonoDatex-Ohmeda, Inc. · 2000
This deviceK052167 Datex-Ohmeda S/5 Tonometry Module, E Tono and AccessoriesGE Healthcare · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K962638	Tonocap, TC-200 and Accessory Catheters	Instrumentarium Corp.	1997	—
−1	K993656	Datex-Ohmeda Tonometry Module M-Tono	Datex-Ohmeda, Inc.	2000	—
0 (this device)	K052167	Datex-Ohmeda S/5 Tonometry Module, E Tono and Accessories	GE Healthcare	2005	—

FIG. 1 — Lineage of K052167, 1997–2005Source: 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 CCK? 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 CCK device

#1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 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
*	K993656	Datex-Ohmeda Tonometry Module M-Tono Summary page 1 …atex-Ohmeda S/5TM Tonometry Module, E-TONO is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-TONO Module (K993656). Page 2 of 3 DEVICE DESCRIPTION as required by 807.92(a)(4) The Datex-Ohmeda Tonometry module, E-TONO is a single-width plu…	Datex-Ohmeda, Inc.	2000	—

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 8 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All CCK devices

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

FDA decisions per year · CCK

3in 2025

2007high 9 (2014) · low 2 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCK

169in 2025

2007high 592 (2024) · low 56 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CCK

1in 2022

2007high 19 (2009) · low 0 (2007)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · CCK

1,259in 2025

2007high 2,475 (2022) · low 7 (2007)2025

MAUDE reports naming product code CCK, 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	5	56	0	7
2008	3	248	1	20
2009	3	101	19	21
2010	3	125	4	12
2011	2	—	14	18
2012	7	150	3	13
2013	4	132	2 (1)	28
2014	9	166	0	51
2015	5	105	1	114
2016	2	—	0	88
2017	5	134	0	58
2018	6	296	5	63
2019	7	261	7 (7)	141
2020	4	188	1	2,302
2021	4	227	0	2,272
2022	3	226	1	2,475
2023	4	555	0	1,637
2024	3	592	0	1,216
2025	3	169	0	1,259
2026	3	224	0	—

What is it indicated for?

The Datex-Ohmeda Tonometry Module is indicated for monitoring gastrointestinal C02 (PgCO2) and calculation of various gastrointestinal tonometry parameters (gastrointestinal - arterial PCO2 difference, gastrointestinal - end-tidal PCO2 difference and intramucosal pH) when used with a Datex-Ohmeda modular monitoring system. It is indicated for use in hospital patients.

The Tonometry module is indicated for use by qualified medical personnel only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052167 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052167: Datex-Ohmeda S/5 Tonometry Module, E Tono and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052167

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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