510(k) · Cleared

Recalled · Class II · 2012

Flowtron Universal, Model AC600

K010744510(k) TraditionalCleared Mar 26, 2002378-day reviewClass II21 CFR 870.5800Recalls 1

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

Huntleigh Healthcare, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Mar 26, 2002 after a 378-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it. It has been recalled once.

Decided: Mar 26, 2002
Review: 378 days
Class: Class II
Product code: JOW
Recalls: 1
Predicates: 0

21 later devices descend from it, 7 citing it directly.

This deviceK010744 Flowtron Universal, Model AC600Huntleigh Healthcare, Inc. · 2002
Descendant · cites it directly · 6 of its ownK130571 Devon Cirona 6100 DVTDevon Medical, Inc. · 2013
Descendant · cites it directly · 6 of its ownK110977 VesoflowCaremed Supply, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK141064 Vesoflow Plus DVT Compression DeviceCaremed Supply, Inc. · 2014
Descendant · cites it directly · 4 of its ownK141578 Devon Cirona 6200 DVTDevon Medical · 2014
Descendant · cites it directly · 2 of its ownK133119 Flowtron ACS800 Pump and Tri Pulse GarmentsArjohuntleigh Polska SP Z.O.O. · 2014

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2006high 3 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 21 · See all

K130571Devon Cirona 6100 DVTDevon Medical, Inc. · 2013 · cites it directly6descendants
K110977VesoflowCaremed Supply, Inc. · 2011 · cites it directly6descendants
K141064Vesoflow Plus DVT Compression DeviceCaremed Supply, Inc. · 2014 · 2 generations on4descendants
K141578Devon Cirona 6200 DVTDevon Medical · 2014 · cites it directly4descendants
K133119Flowtron ACS800 Pump and Tri Pulse GarmentsArjohuntleigh Polska SP Z.O.O. · 2014 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010744	Flowtron Universal, Model AC600	Huntleigh Healthcare, Inc.	2002	—
+1	K130571	Devon Cirona 6100 DVT	Devon Medical, Inc.	2013	—
+1	K110977	Vesoflow	Caremed Supply, Inc.	2011	—
+2	K141064	Vesoflow Plus DVT Compression Device	Caremed Supply, Inc.	2014	—
+1	K141578	Devon Cirona 6200 DVT	Devon Medical	2014	—
+1	K133119	Flowtron ACS800 Pump and Tri Pulse Garments	Arjohuntleigh Polska SP Z.O.O.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2009	1	0
2010	1	0
2011	1	0
2013	3	0
2014	3	0
2015	1	0
2018	1	0
2019	2	0
2020	2	0
2021	1	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K010744, 2002–2026Source: 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

Get a 510(k) Report

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? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K130571	Devon Cirona 6100 DVT	Devon Medical, Inc.	2013	6
K110977	Vesoflow	Caremed Supply, Inc.	2011	6
K141578	Devon Cirona 6200 DVT	Devon Medical	2014	4
K133119	Flowtron ACS800 Pump and Tri Pulse Garments	Arjohuntleigh Polska SP Z.O.O.	2014	2
K090074	Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs	Hygia Health Services, Inc.	2009	1
K072372	Phlebopress Model 601A Compression Therapy Device	Mego Afek	2007	0
K052691	Suretek Medical Reprocessed Compression Sleeves	Suretek Medical	2006	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 10, 2012	Class II	Z-0615-2013	No Marketing Application	The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K130571 (Devon Medical, Inc., 2013) has gone furthest, with 6 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/K010744 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010744: Flowtron Universal, Model AC600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010744

Report an extraction error

Are you the manufacturer?

Record history

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