510(k) · Cleared

Cleared

B&J DVT Calf/Thigh Garments, Models 801/830 Series

K201532510(k) TraditionalCleared Sep 19, 2020103-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

B&J Manufacturing, Ltd. · JOW Sleeve, Limb, Compressible

Cleared on Sep 19, 2020 as substantially equivalent to K061967 (Compression Therapy Concepts, Inc., 2006) after a 103-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.

Decided: Sep 19, 2020
Review: 103 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K061967 (2006). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK061967 SCD Garment, Model VP530Compression Therapy Concepts, Inc. · 2006
This deviceK201532 B&J DVT Calf/Thigh Garments, Models 801/830 SeriesB&J Manufacturing, Ltd. · 2020
Descendant · cites it directly · 0 of its ownK253386 DVT GarmentVistar Medical Supplies Co., Ltd. · 2026

Most influential descendants

Showing 1 of 1 · See all

K253386DVT GarmentVistar Medical Supplies Co., Ltd. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K061967	SCD Garment, Model VP530	Compression Therapy Concepts, Inc.	2006	—
0 (this device)	K201532	B&J DVT Calf/Thigh Garments, Models 801/830 Series	B&J Manufacturing, Ltd.	2020	—
+1	K253386	DVT Garment	Vistar Medical Supplies Co., Ltd.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K201532, 2006–2026Source: 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 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? (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
*	K061967	SCD Garment, Model VP530 Summary page 5 …ar I 3-1 DVT Calf /Thigh Garments 801/830 Series 510(k) Submission 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] Primary Predicate K061967 - VasoQuential, Model VP530 Reference Device K991038 - VasoPress DVT Calf Garments VP 501 5. Description of the Device [21 CFR…	Compression Therapy Concepts, Inc.	2006	—
†	K991038	Vaso Press DVT System, Models VP500, VP501	Britt Corp., Inc.	2000	—

Also cleared against K061967: 3 other devices →

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
K253386	DVT Garment	Vistar Medical Supplies Co., Ltd.	2026	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?

Its one ancestor has no recall.
Of its descendants, K253386 (Vistar Medical Supplies Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K061967.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?

The B&J DVT Calf/Thigh Garments, Models 801/830 Series are designed to increase venous blood flow in at risk patients in order to help lower the risk of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K201532 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201532: B&J DVT Calf/Thigh Garments, Models 801/830 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201532

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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