510(k) · Cleared

Cleared

ReDs Wearable System

K150095510(k) TraditionalCleared Aug 6, 2015202-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

Sensible Medical Innovations, Ltd. · DSB Plethysmograph, Impedance

Cleared on Aug 6, 2015 as substantially equivalent to K131509 (Noninvasive Medical Technologies, Inc., 2013) and 5 other predicates after a 202-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.

Decided: Aug 6, 2015
Review: 202 days
Class: Class II
Product code: DSB
Recalls: None
Predicates: 6

Its longest line of descent runs back 5 generations to K000126 (2000). 12 ancestors in all, the oldest K922218 (1992). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
4 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
3 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
2 generations backK070985 Aesculon CHF, Hypertension & Pacemaker ClinicOsypka Medical, Inc. · 2008
1 generation backK081035 Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2…Osypka Medical, Inc. · 2008
This deviceK150095 ReDs Wearable SystemSensible Medical Innovations, Ltd. · 2015
Descendant · cites it directly · 0 of its ownK180479 ReDS SystemSensible Medical Innovations, Ltd. · 2019

Most influential descendants

Showing 1 of 1 · See all

K180479ReDS SystemSensible Medical Innovations, Ltd. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K000126	Masimo Set Radical Pulse Oximeter with Satshare, Masimo…	Masimo Corp.	2000	—
−4	K031330	Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop…	Masimo Corp.	2003	—
−3	K033296	Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse…	Masimo Corp.	2004	1
−2	K070985	Aesculon CHF, Hypertension & Pacemaker Clinic	Osypka Medical, Inc.	2008	—
−1	K081035	Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and…	Osypka Medical, Inc.	2008	—
0 (this device)	K150095	ReDs Wearable System	Sensible Medical Innovations, Ltd.	2015	—
+1	K180479	ReDS System	Sensible Medical Innovations, Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1999	1	0
2001	1	0
2004	1	0
2012	1	0
2013	1	0
2014	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K150095, 2000–2019Source: 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? (6)

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
*	K131509	Zoe Fluid Status Monitor Summary page 5 …K150095 Predicate Devices:  ZOE Fluid Status Monitor (NMT Medical), product code DSB, cleared for marketing under K131509, K112830, K042113, K133301 (primary predicate)  Aesculon (Osypka Medical), product code DSB, cleared for marketin…	Noninvasive Medical Technologies, Inc.	2013	—
*	K112830	Zoefluid Status Monitor (Model Zoe 2B) Summary page 5 …K150095 Predicate Devices:  ZOE Fluid Status Monitor (NMT Medical), product code DSB, cleared for marketing under K131509, K112830, K042113, K133301 (primary predicate)  Aesculon (Osypka Medical), product code DSB, cleared for marketing…	Noninvasive Medical Technologies, Inc.	2012	—
*	K042113	Zoe Fluid Status Monitor Summary page 5 …K150095 Predicate Devices:  ZOE Fluid Status Monitor (NMT Medical), product code DSB, cleared for marketing under K131509, K112830, K042113, K133301 (primary predicate)  Aesculon (Osypka Medical), product code DSB, cleared for marketing under K0…	Noninvasive Medical Technologies, LLC	2004	—
*	K133301	Zoe Fluid Status Monitor Summary page 5 …K150095 Predicate Devices:  ZOE Fluid Status Monitor (NMT Medical), product code DSB, cleared for marketing under K131509, K112830, K042113, K133301 (primary predicate)  Aesculon (Osypka Medical), product code DSB, cleared for marketing under K070985, K0…	Noninvasive Medical Technologies, Inc.	2014	—
*	K070985	Aesculon CHF, Hypertension & Pacemaker Clinic Summary page 5 …marketing under K131509, K112830, K042113, K133301 (primary predicate)  Aesculon (Osypka Medical), product code DSB, cleared for marketing under K070985, K081035 Indications for Use: ReDS is intended for use by qualified health care practitioners and by patients, under the direct…	Osypka Medical, Inc.	2008	—
*	K081035	Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon… Summary page 5 …g under K131509, K112830, K042113, K133301 (primary predicate)  Aesculon (Osypka Medical), product code DSB, cleared for marketing under K070985, K081035 Indications for Use: ReDS is intended for use by qualified health care practitioners and by patients, under the direction of a…	Osypka Medical, Inc.	2008	—

Also cleared against K131509: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K180479	ReDS System	Sensible Medical Innovations, Ltd.	2019	0

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 15 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
1 of the 12 ancestors has a recall of any class.
Of its descendants, K180479 (Sensible Medical Innovations, Ltd., 2019) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K131509.

How does its category compare?

All DSB devices

DSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?

ReDS is intended for use by qualified health care practitioners and by patients, under the direction of a physician, in hospitals, hospital-type facilities and home environment, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

ReDS is indicated for patients:

With fluid management problems

Taking diuretic medication

Living with Heart Failure

Recovering from Coronary Artery Disease related event

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150095 · printed Nov 4, 2026

Cite this page

510(k) Report. “K150095: ReDs Wearable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150095

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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