510(k) · Cleared

Cleared

Jsa's Reprocessed Compression Sleeve Devices

K040065510(k) TraditionalCleared Mar 29, 200476-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

Jack Speer and Assoc., Inc. · JOW Sleeve, Limb, Compressible

Cleared on Mar 29, 2004 as substantially equivalent to K881632 (Huntleigh Technology, Inc., 1988) after a 76-day review. Its family tree reaches back 1 generation to 1988.

Decided: Mar 29, 2004
Review: 76 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K881632 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
This deviceK040065 Jsa's Reprocessed Compression Sleeve DevicesJack Speer and Assoc., Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K881632	Flowtron DVT System AC500 Pump, L501 Garment	Huntleigh Technology, Inc.	1988	—
0 (this device)	K040065	Jsa's Reprocessed Compression Sleeve Devices	Jack Speer and Assoc., Inc.	2004	—

FIG. 1 — Lineage of K040065, 1988–2004Source: 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
*	K881632	Flowtron DVT System AC500 Pump, L501 Garment Summary page 1 …II per 21 CFR 870.5800 Panel Number: Panel 70 Product Code: JOW Predicate Device: The JSA Reprocessed CSD is substantially equivalent to the legally marketed Huntleigh K881632 Compression Sleeve Predicate Devices. Device Description: Huntleigh's compression sleeve device (CSD) is an SUD component of Hu…	Huntleigh Technology, Inc.	1988	—

Also cleared against K881632: 9 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?

Its one ancestor has no recall.
9 other devices also cite its predicate K881632.

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	—

What is it indicated for?

The Jack Speer and Associates, Inc. Huntleigh Reprocessed Compression Sleeve is recommended for use in patients for whom external compression therapy using the Huntleigh Flowtron® System is indicated for the prevention of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombus formation. Intraoperative compression therapy is frequently indicated, sometimes adjunctively with medical measures, during orthopedic, trauma, urologic and general surgery, particularly in patients over the age of 40.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040065 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040065: Jsa's Reprocessed Compression Sleeve Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040065

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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