510(k) · Cleared

Cleared

Datex-Ohmeda Tonometry Module M-Tono

K993656510(k) TraditionalCleared Mar 15, 2000138-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

Datex-Ohmeda, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Mar 15, 2000 as substantially equivalent to K962638 (Instrumentarium Corp., 1997) after a 138-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Mar 15, 2000
Review: 138 days
Class: Class II
Product code: CCK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962638 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK962638 Tonocap, TC-200 and Accessory CathetersInstrumentarium Corp. · 1997
This deviceK993656 Datex-Ohmeda Tonometry Module M-TonoDatex-Ohmeda, Inc. · 2000
Descendant · cites it directly · 0 of its ownK052167 Datex-Ohmeda S/5 Tonometry Module, E Tono and AccessoriesGE Healthcare · 2005

Most influential descendants

Showing 1 of 1 · See all

K052167Datex-Ohmeda S/5 Tonometry Module, E Tono and AccessoriesGE Healthcare · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K993656, 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
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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
*	K962638	Tonocap, TC-200 and Accessory Catheters Summary page 1 …IVALENCE IS MADE as required by 807.92(a)(3) The Datex-Ohmeda Tonometry Module, M-TONO is substantially equivalent to the legally marketed (predicate) Tonocap™ Monitor (K962638). Datex-Ohmeda, Inc. Telephone: 800-635-6099 Three Highwood Drive 978-640-0460 Tewksbury, MA 01876 Facsimile: 978-640-0469 www.…	Instrumentarium Corp.	1997	—

Also cleared against K962638: 1 other device →

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
K052167	Datex-Ohmeda S/5 Tonometry Module, E Tono and Accessories	GE Healthcare	2005	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, K052167 (GE Healthcare, 2005) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K962638.

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, M-TONO is indicated for monitoring gastrointestinal CO2 (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.

This device is indicated for use by qualified medical personnel only.

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/K993656 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993656: Datex-Ohmeda Tonometry Module M-Tono.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993656

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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