510(k) · Cleared

Cleared

ETCO2 Vital Signs Module

K983864510(k) TraditionalCleared Oct 8, 1999340-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

Mennen Medical, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Oct 8, 1999 as substantially equivalent to K940081 (Mennen Medical, Inc., 1995) and 1 other predicate after a 340-day review. Its family tree reaches back 1 generation to 1994.

Decided: Oct 8, 1999
Review: 340 days
Class: Class II
Product code: CCK
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K935272 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK935272 CAP 400 ATPryon Corp. · 1994
This deviceK983864 ETCO2 Vital Signs ModuleMennen Medical, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935272	CAP 400 AT	Pryon Corp.	1994	—
0 (this device)	K983864	ETCO2 Vital Signs Module	Mennen Medical, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K983864, 1994–1999Source: 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

Get a 510(k) Report

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
*	K940081	Mercury Summary page 1 …Standards None promulgated Voluntary Standards IEC 601-1, IEC 601-1-1, IEC 601-1-2, IEC 601-1-4, EN1441, AAMI/ANSI Standards Predicate Devices MENNEN MEDICAL MERCURY (K940081) PRYON SC300 (CAP 400 AT - K935272) Date Prepared: 30 October 1998 Date Revised: 29 August 1999 Food and Drug Ad…	Mennen Medical, Inc.	1995	—
*	K935272	CAP 400 AT Summary page 1 …ary Standards IEC 601-1, IEC 601-1-1, IEC 601-1-2, IEC 601-1-4, EN1441, AAMI/ANSI Standards Predicate Devices MENNEN MEDICAL MERCURY (K940081) PRYON SC300 (CAP 400 AT - K935272) Date Prepared: 30 October 1998 Date Revised: 29 August 1999 Food and Drug Administration 510(k) Summary, ENVOY…	Pryon Corp.	1994	—

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?

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 ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, Pulse Oximetry and EtCO2. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient’s medical condition.

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/K983864 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983864: ETCO2 Vital Signs Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983864

Report an extraction error

Are you the manufacturer?

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