510(k) · Cleared

Cleared

ASI Plethysmogrpah Analyzer

K200567510(k) TraditionalCleared Feb 26, 2021359-day reviewClass II21 CFR 870.2780

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

Arterial Stiffness, Inc. · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Cleared on Feb 26, 2021 as substantially equivalent to K023238 (Meridian Co., Ltd., 2003) and 1 other predicate after a 359-day review. Its family tree reaches back 2 generations to 1985.

Decided: Feb 26, 2021
Review: 359 days
Class: Class II
Product code: JOM
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K853124 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK853124 Novametrix Pulse Oximeter, Model 500Novametrix Medical Systems, Inc. · 1985
1 generation backK023238 McpulseMeridian Co., Ltd. · 2003
This deviceK200567 ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc. · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K853124	Novametrix Pulse Oximeter, Model 500	Novametrix Medical Systems, Inc.	1985	—
−1	K023238	Mcpulse	Meridian Co., Ltd.	2003	—
0 (this device)	K200567	ASI Plethysmogrpah Analyzer	Arterial Stiffness, Inc.	2021	—

FIG. 1 — Lineage of K200567, 1985–2021Source: 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 JOM? 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 JOM device

#1 K220527 PADnet Xpressscore 5.1 · 4 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? (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
*	K023238	Mcpulse Summary page 4 …2. Equivalent legally marketed devices • This product is similar in function to the McPulse Photoelectric Plethysmograph (AKA Meridian DPA) 510(k) No. K023238, Applicant Meridian Co. Ltd. • Also, Novametrix Pulse Oximeter, Model 500, 510(k) K853124 3. Indications for Use (intend…	Meridian Co., Ltd.	2003	—
*	K853124	Novametrix Pulse Oximeter, Model 500 Summary page 4 …se Photoelectric Plethysmograph (AKA Meridian DPA) 510(k) No. K023238, Applicant Meridian Co. Ltd. • Also, Novametrix Pulse Oximeter, Model 500, 510(k) K853124 3. Indications for Use (intended use): • The device provides non-invasive measurement of pulse waveform and heart rate…	Novametrix Medical Systems, Inc.	1985	—
†	K822909	Pulse Oximeter Model 100	Nellcor, Inc.	1982	—

Also cleared against K023238: 5 other devices →

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?

The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 18.0 years on median.
None of the 2 ancestors has a recall.
5 other devices also cite its predicate K023238.

How does its category compare?

All JOM devices

JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · JOM

2in 2022

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOM

Too few JOM 510(k)s in any year since 2007 to give a median.

Recalls per year · JOM

No recall names JOM since 2007.

Adverse event reports per year · JOM

1in 2007

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code JOM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	1
2008	0	—	0
2009	1	—	0
2010	2	—	0
2011	1	—	0
2012	1	—	0
2013	2	—	0
2014	0	—	0
2015	2	—	0
2016	0	—	0
2017	1	—	0
2018	1	—	0
2019	0	—	0
2020	2	—	0
2021	1	—	0
2022	2	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography.

For Professional Use only.

Not for use in individuals under the age of 18 years.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200567 · printed Nov 3, 2026

Cite this page

510(k) Report. “K200567: ASI Plethysmogrpah Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200567

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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