510(k) · Cleared

Cleared

Amadeus Adaptive Compression Therapy

K071763510(k) TraditionalCleared Mar 7, 2008252-day reviewClass II21 CFR 870.5800

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

Convatec · JOW Sleeve, Limb, Compressible

Cleared on Mar 7, 2008 as substantially equivalent to K012994 (Medical Compression Systems (Dbn), Ltd., 2002) and 2 other predicates after a 252-day review. Its family tree reaches back 1 generation to 1988.

Decided: Mar 7, 2008
Review: 252 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K882683 (1988). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK882683 Jobst Extremity Pump (R) System 7500Jobst Institute, Inc. · 1988
This deviceK071763 Amadeus Adaptive Compression TherapyConvatec · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882683	Jobst Extremity Pump (R) System 7500	Jobst Institute, Inc.	1988	—
0 (this device)	K071763	Amadeus Adaptive Compression Therapy	Convatec	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0

FIG. 1 — Lineage of K071763, 1988–2008Source: 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 JOW? 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 JOW device

#1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 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? (3)

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
*	K012994	Wizair DVT Summary page 1 …Device Name: Wiz-Air® DVT Company: Medical Compression Systems (DBN) Ltd. 510(k) Number: K012994 Classification: Compressible limb sleeve (21 CFR §870.5800) Device Name: Ext…	Medical Compression Systems (Dbn), Ltd.	2002	—
*	K882683	Jobst Extremity Pump (R) System 7500 Summary page 1 …870.5800) Device Name: Extremity Pump" 7500 Company: Jobst Institute 510(k) Number: K882683 Classification: Compressible limb sleeve (21 CFR §870.5800) ConvaTec, A Division of E-R. Squibb and…	Jobst Institute, Inc.	1988	—
*	K043423	Model SC-3008 Sequential Circulator Summary page 2 …vice Name: Model SC-3008 Sequential Circulator Company: Bio Compression Systems, Inc. 510(k) Number: K043423 Classification: Compressible limb sleeve (21 CFR §870.5800) In addition, a modified versi…	Bio Compression Systems, Inc.	2005	—

Also cleared against K012994: 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?

None of the 3 ancestors has a recall.
5 other devices also cite its predicate K012994.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · JOW

7in 2025

2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007high 252 (2026) · low 63 (2012)2026

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

Recalls per year · JOW

1in 2019

2007high 7 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JOW

24in 2025

2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, 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	6	66	0	12
2008	4	112	7	36
2009	3	84	0	45
2010	18	71	2	66
2011	11	104	3	50
2012	13	63	2	100
2013	17	94	0	169
2014	16	91	0	93
2015	10	160	0	137
2016	9	121	0	150
2017	9	116	1	149
2018	11	136	0	114
2019	11	88	1	102
2020	14	158	0	50
2021	16	132	0	34
2022	7	80	0	27
2023	6	160	0	57
2024	8	197	0	30
2025	7	168	0	24
2026	6	252	0	—

What is it indicated for?

Amadeus Adaptive Compression Therapy provides optimized graduated compression in both sustained and intermittent settings for use in:

- Enhancing venous return

- Reducing venous leg ulcer healing time

- Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers

- Treatment of chronic venous insufficiency

- Reducing edema due to venous stasis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071763 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071763: Amadeus Adaptive Compression Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071763

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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