510(k) · Cleared
ClearedIC-1545-DL Multi Flo DVT Combo Intermittent Pneumatic Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Compression Systems, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Jul 22, 2013 as substantially equivalent to K061857 (Bio Compression Systems, Inc., 2006) after a 76-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Jul 22, 2013
- Review
- 76 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881632 (1988). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK881632 Flowtron DVT System AC500 Pump, L501 GarmentHuntleigh Technology, Inc. · 1988
- 1 generation backK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
- This deviceK131306 IC-1545-DL Multi Flo DVT Combo Intermittent Pneumatic Compression…Bio Compression Systems, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK180248 VascuEase IC-1200-WHBio Compression Systems, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK232270 DVT Motion Pneumatic Compression DeviceKoge Micro Tech Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881632 | Flowtron DVT System AC500 Pump, L501 Garment | Huntleigh Technology, Inc. | 1988 | — |
| −1 | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent Circulator | Bio Compression Systems, Inc. | 2006 | — |
| 0 (this device) | K131306 | IC-1545-DL Multi Flo DVT Combo Intermittent Pneumatic Compression Device | Bio Compression Systems, Inc. | 2013 | — |
| +1 | K180248 | VascuEase IC-1200-WH | Bio Compression Systems, Inc. | 2018 | — |
| +2 | K232270 | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorSummary page 4…e illustrating the similarities and differences is provided below. Table of Similarities and Differences with the Predicate Device . Digital - Predicate K061857 . Parameter Models IC-1545-KT and -F G LM Flo KT and F: Prophylaxis of deep vein thrombosis. : F: enhancement of venous and arter… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180248 | VascuEase IC-1200-WH | 2018 | 1 |
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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 17.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K180248 (Bio Compression Systems, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K061857.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JOW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 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 GID-3045-T Calf/Thigh or GID-3045-K Calf 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
Reduction of acute or chronic edema
Reduction of lower limb pain due to surgery or trauma
Reduction of compartment pressures
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/K131306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131306: IC-1545-DL Multi Flo DVT Combo Intermittent Pneumatic Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131306
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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