510(k) · Cleared

Cleared

Flowtron Foot Garment-Regular-Sterile Flowtron Foot Garment-Large-Sterile

K122330510(k) SpecialCleared Dec 7, 2012127-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

Arjohuntleigh Polska SP Z.O.O. · JOW Sleeve, Limb, Compressible

Cleared on Dec 7, 2012 as substantially equivalent to K965153 (Huntleigh Healthcare, Inc., 1998) after a 127-day review. Its family tree reaches back 1 generation to 1998.

Decided: Dec 7, 2012
Review: 127 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K965153 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK965153 Huntleigh FP5000 System Model FP5000Huntleigh Healthcare, Inc. · 1998
This deviceK122330 Flowtron Foot Garment-Regular-Sterile Flowtron Foot…Arjohuntleigh Polska SP Z.O.O. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K965153	Huntleigh FP5000 System Model FP5000	Huntleigh Healthcare, Inc.	1998	—
0 (this device)	K122330	Flowtron Foot Garment-Regular-Sterile Flowtron Foot Garment-Large-Sterile	Arjohuntleigh Polska SP Z.O.O.	2012	—

FIG. 1 — Lineage of K122330, 1998–2012Source: 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
*	K965153	Huntleigh FP5000 System Model FP5000 Summary page 1 …ation 11 JOW 21 CFR 870.5800 Classification Name: Sleeve, Uimb, Compressible Predicate Device: K965153, Huntleigh FP5000 System, Model FP5000 Indications for Use: 0 Prevention of Deep Vein Thrombosis (DVT)…	Huntleigh Healthcare, Inc.	1998	—

Also cleared against K965153: 1 other device →

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.
1 other device also cites its predicate K965153.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?

Prevention of Deep Vein Thrombosis (DVT)

Enhancement of venous & arterial circulation

Prevention of venous stasis

Assist healing of cutaneous ulcers

Reduction of acute or chronic edema

Reduction of lower limb pain due to surgery or trauma

Reduction of compartmental pressures

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122330 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122330: Flowtron Foot Garment-Regular-Sterile Flowtron Foot Garment-Large-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122330

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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