510(k) · Cleared

Cleared

Fukuda Denshi Model HC-500 End Tidal CO2 Module

K980979510(k) TraditionalCleared Jun 12, 199887-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

Fukuda Denshi USA, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Jun 12, 1998 as substantially equivalent to K950044 (Fukuda Denshi USA, Inc., 1995) after an 87-day review. Its family tree reaches back 1 generation to 1995.

Decided: Jun 12, 1998
Review: 87 days
Class: Class II
Product code: CCK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K950044 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK950044 Fukuda Denshi Model HC-300 End Tidal CO2 ModuleFukuda Denshi USA, Inc. · 1995
This deviceK980979 Fukuda Denshi Model HC-500 End Tidal CO2 ModuleFukuda Denshi USA, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950044	Fukuda Denshi Model HC-300 End Tidal CO2 Module	Fukuda Denshi USA, Inc.	1995	—
0 (this device)	K980979	Fukuda Denshi Model HC-500 End Tidal CO2 Module	Fukuda Denshi USA, Inc.	1998	—

FIG. 1 — Lineage of K980979, 1995–1998Source: 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 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
*	K950044	Fukuda Denshi Model HC-300 End Tidal CO2 Module Summary page 1 …TCO, Gas Module Classification Name: Carbon Dioxide Gas Analyzer (§869.1400) Legally Marketed Device: : FUKUDA DENSHI niiodel HC-300 End Tidal CO, Module 510(k) number K950044. (The HC-500 is an addition to the to the DS-5300, 510(k), K964187.) HC-500 510(k) Submission March 9, 1998 Section 2.doc Page 1…	Fukuda Denshi USA, Inc.	1995	—
†	K964187	Fukada Denshi Dynascope Model DS-5300 Patient Monitor	Fukuda Denshi USA, Inc.	1997	—

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?

Its one ancestor has no 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 Fukuda Denshi model HC-500 End Tidal CO2 Module is indicated in those situation where it is desirable to perform real-time end tidal or inspired carbon dioxide concentration and/or respiration rate monitoring of intubated adult, infant and/or neonate patients who are under the care of a physician, within the confines of a health care facility.

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/K980979 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980979: Fukuda Denshi Model HC-500 End Tidal CO2 Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980979

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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