510(k) · Cleared

Recalled · Class II · 2025

vital signs monitor

K180380510(k) TraditionalCleared Dec 21, 2018312-day reviewClass II21 CFR 870.2700Recalls 1

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

Cleared on Dec 21, 2018 as substantially equivalent to K131818 (Edan Instruments, Inc., 2013) after a 312-day review. Its family tree reaches back 3 generations to 2010. It has been recalled once.

Decided: Dec 21, 2018
Review: 312 days
Class: Class II
Product code: DQA
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K102835 (2010). 5 ancestors in all, the oldest K003313 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK102835 Vital Signs MonitorEdan Instruments, Inc. · 2010
2 generations backK120144 Vital Signs MonitorEdan Instruments, Inc. · 2012
1 generation backK131818 Vital Signs MonitorEdan Instruments, Inc. · 2013 · Recalled
This deviceK180380 vital signs monitorEdan Instruments, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K102835	Vital Signs Monitor	Edan Instruments, Inc.	2010	—
−2	K120144	Vital Signs Monitor	Edan Instruments, Inc.	2012	—
−1	K131818	Vital Signs Monitor	Edan Instruments, Inc.	2013	2
0 (this device)	K180380	vital signs monitor	Edan Instruments, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2011	1	0

FIG. 1 — Lineage of K180380, 2010–2018Source: 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
*	K131818	Vital Signs Monitor Summary page 4 …L Regulatory Class: Class II 3. Predicate Device(s): 1) Edan Instruments, Inc, Vital Signs Monitor Model M3, K131818(Primary) 2) Edan Instruments, Inc, Patient Monitor Model V5 V6 V8, K160981…	Edan Instruments, Inc.	2013	2
†	K160981	Patient Monitor	Edan Instruments, Inc.	2016	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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 24, 2025	Class II	Z-1143-2026	Device Design	As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm 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 1 company; a new generation was cleared every 1.5 years on median.
1 of the 5 ancestors has a recall of any class.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

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 monitor is intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitor is intended for use by trained healthcare professionals in hospital environments.

Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP.

The monitor is not intended for MRI environments. TEMP module is not intended for neonates.

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/K180380 · printed Nov 5, 2026

Cite this page

510(k) Report. “K180380: vital signs monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180380

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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