510(k) · Cleared

Cleared

Wizair Compression System

K002287510(k) SpecialCleared Aug 25, 200029-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

Medical Compression Systems (Dbn), Ltd. · JOW Sleeve, Limb, Compressible

Cleared on Aug 25, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 64 later devices descend from it.

Decided: Aug 25, 2000
Review: 29 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 0

64 later devices descend from it, 4 citing it directly.

This deviceK002287 Wizair Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
Descendant · cites it directly · 31 of its ownK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
Descendant · 2 generations on · 30 of its ownK061125 Dvtcare CA5Doctors Orders · 2006
Descendant · cites it directly · 30 of its ownK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
Descendant · 2 generations on · 25 of its ownK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
Descendant · 2 generations on · 22 of its ownK133274 Vena ProInnovamed Health, LLC · 2014

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2003high 9 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 64 · See all

K022340Travelair Portable Compression SystemDynamic Air, Inc. · 2003 · cites it directly31descendants
K061125Dvtcare CA5Doctors Orders · 2006 · 2 generations on30descendants
K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · cites it directly30descendants
K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011 · 2 generations on25descendants
K133274Vena ProInnovamed Health, LLC · 2014 · 2 generations on22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002287	Wizair Compression System	Medical Compression Systems (Dbn), Ltd.	2000	—
+1	K022340	Travelair Portable Compression System	Dynamic Air, Inc.	2003	—
+2	K061125	Dvtcare CA5	Doctors Orders	2006	—
+1	K060146	Activecare ++ System	Medical Compression Systems (Dbn), Ltd.	2006	1
+2	K103187	Tripleplay-VT Vascular Therapy System	Wildcat Medical, Inc.	2011	—
+2	K133274	Vena Pro	Innovamed Health, LLC	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2006	4	0
2007	2	0
2008	1	0
2010	2	0
2011	5	0
2012	4	0
2013	2	0
2014	3	0
2015	3	0
2016	3	0
2017	3	0
2018	3	0
2019	4	0
2020	6	0
2021	9	0
2023	2	0
2024	5	0
2026	1	0

FIG. 1 — Lineage of K002287, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (64)

See all 64

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022340	Travelair Portable Compression System	Dynamic Air, Inc.	2003	31
K060146	Activecare ++ System	Medical Compression Systems (Dbn), Ltd.	2006	30
K041659	C-BOOT	C-Boot, Ltd.	2004	2
K051438	Vanguard Reprocessed Compression Garments (Hill-Rom)	Alliance Medical, Inc.	2006	1

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?

Of its descendants, K022340 (Dynamic Air, Inc., 2003) has gone furthest, with 31 descendants of its own.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

https://510kreport.com/device/K002287 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002287: Wizair Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002287

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026