510(k) · Cleared

Cleared

Flowmedic, Model 220

K042217510(k) TraditionalCleared Jan 12, 2005149-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

Flowmedic (Israel), Ltd. · JOW Sleeve, Limb, Compressible

Cleared on Jan 12, 2005 as substantially equivalent to K024019 (Aircast, Inc., 2003) and 2 other predicates after a 149-day review. Its family tree reaches back 1 generation to 1996.

Decided: Jan 12, 2005
Review: 149 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K942530 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK942530 Art-Assist Model AA-1000Aci Medical, Inc. · 1996
This deviceK042217 Flowmedic, Model 220Flowmedic (Israel), Ltd. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K942530	Art-Assist Model AA-1000	Aci Medical, Inc.	1996	—
0 (this device)	K042217	Flowmedic, Model 220	Flowmedic (Israel), Ltd.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0

FIG. 1 — Lineage of K042217, 1996–2005Source: 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? (3)

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
*	K024019	Arterialflow System, Model 32A Summary page 3 …Cardiovascular 7-4 Predicate Devices: • The ArterialFlowTM System (Aircast, Inc), cleared under K024019 * The ArtAssist® Model AA-1000 (ACI Medical, Inc.), cleared under K942530 * WizAir DVTTM (Medical Comp…	Aircast, Inc.	2003	—
*	K942530	Art-Assist Model AA-1000 Summary page 3 …• The ArterialFlowTM System (Aircast, Inc), cleared under K024019 * The ArtAssist® Model AA-1000 (ACI Medical, Inc.), cleared under K942530 * WizAir DVTTM (Medical Compression Systems (DBN) Ltd.), cleared under K012994 Performance Standards:…	Aci Medical, Inc.	1996	—
*	K012994	Wizair DVT Summary page 3 …ArtAssist® Model AA-1000 (ACI Medical, Inc.), cleared under K942530 * WizAir DVTTM (Medical Compression Systems (DBN) Ltd.), cleared under K012994 Performance Standards: No performance standards have been established for such device under Section 514 of the Feder…	Medical Compression Systems (Dbn), Ltd.	2002	—

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?

None of the 3 ancestors has a recall.

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 FlowMedicTM FM220 System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042217 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042217: Flowmedic, Model 220.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042217

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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