510(k) · Cleared

Cleared

Model Multi-Flo IC-1545-KT/-F Intermittent Circulator

K061857510(k) TraditionalCleared Aug 1, 200632-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

Bio Compression Systems, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Aug 1, 2006 as substantially equivalent to K932900 (Aircast, Inc., 1993) and 3 other predicates after a 32-day review. Its family tree reaches back 1 generation to 1988. 22 later devices descend from it.

Decided: Aug 1, 2006
Review: 32 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K881632 (1988). 4 ancestors in all. 22 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
This deviceK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
Descendant · cites it directly · 18 of its ownK072666 Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007
Descendant · 2 generations on · 14 of its ownK131327 Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
Descendant · 3 generations on · 12 of its ownK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
Descendant · 4 generations on · 11 of its ownK190854 Therm-XZenith Technical Innovations · 2019
Descendant · 4 generations on · 10 of its ownK193550 Therm-XZenith Technical Innovations · 2020

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2007high 4 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 22 · See all

K072666Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007 · cites it directly18descendants
K131327Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013 · 2 generations on14descendants
K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018 · 3 generations on12descendants
K190854Therm-XZenith Technical Innovations · 2019 · 4 generations on11descendants
K193550Therm-XZenith Technical Innovations · 2020 · 4 generations on10descendants

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)	K061857	Model Multi-Flo IC-1545-KT/-F Intermittent Circulator	Bio Compression Systems, Inc.	2006	—
+1	K072666	Bioarterial Plus, Arterial Blood Flow Enhancement System	Bio Compression Systems, Inc.	2007	—
+2	K131327	Bioarterial Plus Arterial Blood Flow Enhancement System	Bio Compression Systems, Inc.	2013	—
+3	K181149	Therm-X Pro, Therm-X AT, Therm-X Pro Athlete	Zenith Technical Innovations	2018	—
+4	K190854	Therm-X	Zenith Technical Innovations	2019	—
+4	K193550	Therm-X	Zenith Technical Innovations	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1998	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2010	2	0
2011	1	0
2013	2	0
2018	2	0
2019	1	0
2020	1	0
2023	4	0
2024	4	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K061857, 1988–2026Source: 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? (4)

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
*	K932900	Aircast Venaflow System Summary page 2 …es are classified as Class Il devices, and reviewed by the Division of Cardiovascuiar Devices. 10/263 Koo (857 /Dajé’ 9 of 3 6. PREDICATE DEVICE(s): * K932900 Aircast Inc. Venafliow System * K965153 Huntleigh Healthcare FPS000 * K881632 Huntleigh Healthcare Flowtron DVT ACS500 * K043423…	Aircast, Inc.	1993	—
*	K965153	Huntleigh FP5000 System Model FP5000 Summary page 2 …d reviewed by the Division of Cardiovascuiar Devices. 10/263 Koo (857 /Dajé’ 9 of 3 6. PREDICATE DEVICE(s): * K932900 Aircast Inc. Venafliow System * K965153 Huntleigh Healthcare FPS000 * K881632 Huntleigh Healthcare Flowtron DVT ACS500 * K043423 Model SC-3008 Sequential Circulator 7.…	Huntleigh Healthcare, Inc.	1998	—
*	K881632	Flowtron DVT System AC500 Pump, L501 Garment Summary page 2 …scuiar Devices. 10/263 Koo (857 /Dajé’ 9 of 3 6. PREDICATE DEVICE(s): * K932900 Aircast Inc. Venafliow System * K965153 Huntleigh Healthcare FPS000 * K881632 Huntleigh Healthcare Flowtron DVT ACS500 * K043423 Model SC-3008 Sequential Circulator 7. DEVICE DESCRIPTION: The device is ava…	Huntleigh Technology, Inc.	1988	—
*	K043423	Model SC-3008 Sequential Circulator Summary page 2 …ajé’ 9 of 3 6. PREDICATE DEVICE(s): * K932900 Aircast Inc. Venafliow System * K965153 Huntleigh Healthcare FPS000 * K881632 Huntleigh Healthcare Flowtron DVT ACS500 * K043423 Model SC-3008 Sequential Circulator 7. DEVICE DESCRIPTION: The device is available in two models (-KT and -F) and is infended f…	Bio Compression Systems, Inc.	2005	—

Also cleared against K932900: 1 other device →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K072666	Bioarterial Plus, Arterial Blood Flow Enhancement System	Bio Compression Systems, Inc.	2007	18
K131306	IC-1545-DL Multi Flo DVT Combo Intermittent Pneumatic Compression Device	Bio Compression Systems, Inc.	2013	2

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 4 ancestors has a recall.
Of its descendants, K072666 (Bio Compression Systems, Inc., 2007) has gone furthest, with 18 descendants of its own.
1 other device also cites its predicate K932900.

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?

When used with GI-3045-T Knee/Thigh or GI-3045-K Knee garments:

Intended for prophylaxis of deep vein thrombosis

When used with GI-3045-F Foot garments:

Intended for prophylaxis of deep vein thrombosis

Enhancement of venous and arterial circulation

Prevention of venous stasis ulcers

Assist in healing of cutaneous ulcers

Reduction of acute or chronic edema

Reduction of lower limb pain due to surgery or trauma

Reduction of compartmental pressures

The device is intended for hospital and home use.

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/K061857 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061857: Model Multi-Flo IC-1545-KT/-F Intermittent Circulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061857

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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