510(k) · Cleared

Cleared

Fukuda Denshi Model HG-500, Pulse Oximeter Module

K013273510(k) TraditionalCleared Dec 20, 200180-day reviewClass II21 CFR 870.2700

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

Cleared on Dec 20, 2001 as substantially equivalent to K945464 (Fukuda Denshi USA, Inc., 1995) after an 80-day review. Its family tree reaches back 1 generation to 1995.

Decided: Dec 20, 2001
Review: 80 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945464 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK945464 Fukuda Denshi Mode HG-302 Pulse Oximeter ModuleFukuda Denshi USA, Inc. · 1995
This deviceK013273 Fukuda Denshi Model HG-500, Pulse Oximeter ModuleFukuda Denshi USA, Inc. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945464	Fukuda Denshi Mode HG-302 Pulse Oximeter Module	Fukuda Denshi USA, Inc.	1995	—
0 (this device)	K013273	Fukuda Denshi Model HG-500, Pulse Oximeter Module	Fukuda Denshi USA, Inc.	2001	—

FIG. 1 — Lineage of K013273, 1995–2001Source: 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 DQA? 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 DQA device

#1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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
*	K945464	Fukuda Denshi Mode HG-302 Pulse Oximeter Module Summary page 1 …mon Name: Pulse Oximeter Classification Name: Pulse Oximeter (§870.2700/74DQA) Legally Marketed Device: FUKUDA DENSHI model HG-302 Pulse Oximeter Module 510(k) number K945464. (The HG-500 is an addition to the DS-5300, 501(k) K964187) HG-500 510(k) Submission September 19, 2001 Section 2.doc Page 1 of…	Fukuda Denshi USA, Inc.	1995	—
†	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
†	K993637	N-395 Pulse Oximeter, with Extended Device Claims	Nellcor Puritan Bennett, Inc.	1999	1

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 DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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	20	122	6	325
2008	22	97	5	312
2009	35	117	29	281
2010	29	127	4	185
2011	15	195	1	164
2012	14	120	0	322
2013	15	182	0	468
2014	11	175	2	1,124
2015	13	158	1	2,082
2016	14	246	0	1,775
2017	9	200	0	1,190
2018	18	260	32	694
2019	19	158	0	548
2020	15	126	0	426
2021	10	174	0	553
2022	20	265	0	478
2023	13	317	0	392
2024	14	285	3	545
2025	15	182	0	399
2026	8	187	0	—

What is it indicated for?

The Fukuda Denshi model HG-500 Pulse Oximeter Module is indicated in those situations where it is desirable to perform continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin(SpO2) and pulse rate for adult, pediatric and neonatal patients who are under the care of a physician, within the confines of a health care facility. It is not intended for home use

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/K013273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013273: Fukuda Denshi Model HG-500, Pulse Oximeter Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013273

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026