510(k) · Cleared

Cleared

Cheetah Reliant, Cheetah Active

K072662510(k) TraditionalCleared Jan 16, 2008117-day reviewClass II21 CFR 870.2770

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

Cheetah Medical, Inc. · DSB Plethysmograph, Impedance

Cleared on Jan 16, 2008 as substantially equivalent to K042144 (Cheetah Medical, Inc., 2004) after a 117-day review. Its family tree reaches back 1 generation to 2004. 46 later devices descend from it.

Decided: Jan 16, 2008
Review: 117 days
Class: Class II
Product code: DSB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K042144 (2004). 46 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK042144 NICOMCheetah Medical, Inc. · 2004
This deviceK072662 Cheetah Reliant, Cheetah ActiveCheetah Medical, Inc. · 2008
Descendant · cites it directly · 45 of its ownK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled
Descendant · 2 generations on · 35 of its ownK101487 Cheetah Nicom SystemCheetah Medical, Inc. · 2010
Descendant · 3 generations on · 34 of its ownK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
Descendant · 4 generations on · 27 of its ownK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
Descendant · 5 generations on · 18 of its ownK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2008high 9 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 46 · See all

K083093Cheetah ReliantCheetah Medical, Inc. · 2008 · cites it directly45descendants
K101487Cheetah Nicom SystemCheetah Medical, Inc. · 2010 · 2 generations on35descendants
K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019 · 3 generations on34descendants
K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · 4 generations on27descendants
K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC · 2021 · 5 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K042144	NICOM	Cheetah Medical, Inc.	2004	—
0 (this device)	K072662	Cheetah Reliant, Cheetah Active	Cheetah Medical, Inc.	2008	—
+1	K083093	Cheetah Reliant	Cheetah Medical, Inc.	2008	1
+2	K101487	Cheetah Nicom System	Cheetah Medical, Inc.	2010	—
+3	K190205	HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module	Edwards Lifesciences, LLC	2019	—
+4	K201446	HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module	Edwards Lifesiences, LLC	2020	1
+5	K203687	HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension…	Edwards Lifesciences, LLC	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0
2011	2	0
2012	1	0
2016	1	0
2018	1	0
2019	1	0
2020	1	0
2021	8	0
2022	5	0
2023	9	0
2024	5	0
2025	5	0
2026	5	0

FIG. 1 — Lineage of K072662, 2004–2026Source: 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 DSB? 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 DSB device

#1 K232089 SOZO Proscore 14.6 · 9 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
*	K042144	NICOM Summary page 1 …"Impedance plethymograph") Devices to which substantial equivalence is claimed: 510(k) number Trade or propriety name Manufactumre K042144 Cheetah NICOM System Cheetah Medical, Inc. Device Description The Cheetah Reliant is a portable, non-…	Cheetah Medical, Inc.	2004	—

Also cleared against K042144: 1 other device →

What descends from it? (46)

See all 46

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K083093	Cheetah Reliant	Cheetah Medical, Inc.	2008	45

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.
Of its descendants, K083093 (Cheetah Medical, Inc., 2008) has gone furthest, with 45 descendants of its own.
1 other device also cites its predicate K042144.

How does its category compare?

All DSB devices

DSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DSB

3in 2025

2007high 6 (2008) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSB

266in 2025

2007high 266 (2025) · low 90 (2008)2026

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

Recalls per year · DSB

1in 2015

2007high 1 (2015) · low 0 (2007)2026

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

Adverse event reports per year · DSB

2in 2025

2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code DSB, 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	2	—	0	0
2008	6	90	0	0
2009	2	—	0	0
2010	1	—	0	0
2011	2	—	0	0
2012	1	—	0	0
2013	2	—	0	0
2014	2	—	0	0
2015	2	—	1	0
2016	0	—	0	1
2017	2	—	0	0
2018	1	—	0	0
2019	1	—	0	0
2020	2	—	0	0
2021	1	—	0	0
2022	1	—	0	0
2023	2	—	0	0
2024	0	—	0	0
2025	3	266	0	2
2026	1	—	0	—

What is it indicated for?

The Cheetah Reliant is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah Reliant system is intended to monitor and display a patient's Cardiac Output in units of Ltr/min.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072662 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072662: Cheetah Reliant, Cheetah Active.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072662

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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