510(k) · Cleared
ClearedBio Compression Cold Flo, Single Chamber Intermittent and Multi-Chamber Sequential Models
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Compression Systems, Inc. · ILO Pack, Hot Or Cold, Water Circulating
Cleared on Oct 28, 1996 as substantially equivalent to K921540 (Tempacure Home Care, 1992) after a 199-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Oct 28, 1996
- Review
- 199 days
- Class
- Class II
- Product code
- ILO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921540 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK921540 Cooling/Heating Therapy DeviceTempacure Home Care · 1992
- This deviceK961425 Bio Compression Cold Flo, Single Chamber Intermittent and…Bio Compression Systems, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921540 | Cooling/Heating Therapy Device | Tempacure Home Care | 1992 | — |
| 0 (this device) | K961425 | Bio Compression Cold Flo, Single Chamber Intermittent and Multi-Chamber… | Bio Compression Systems, Inc. | 1996 | — |
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 ILO? 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 ILO device
- #1 K213097 Armory Motionscore 4.7 · 5 generations · no Class I recall
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 | Decided |
|---|---|---|---|
| * | K921540 | Cooling/Heating Therapy DeviceSummary page 1…other devices also serve as predicates for the Cold Flo®. The Cold Flo® is substantially equivalent to the Tempacure, which provides cold or hot therapy, (510(k) number K921540), and the Sequential Circulator, which provides 177187 sequential compression therapy (sold by Bio Compression p… | 1992 |
| * | — | Jobst Cryo/Temp™ Named without a submission number | |
| * | — | Sequential Circulator Named without a submission number |
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.
How does its category compare?
All ILO devicesILO Pack, Hot Or Cold, Water Circulating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ILO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · ILO
Too few ILO 510(k)s in any year since 2007 to give a median.
Recalls per year · ILO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILO
9in 2025
MAUDE reports naming product code ILO, 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 | 2 | — | 0 | 14 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 2 | 17 |
| 2010 | 0 | — | 0 | 171 |
| 2011 | 0 | — | 1 | 241 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 0 | — | 8 | 60 |
| 2014 | 0 | — | 0 | 49 |
| 2015 | 0 | — | 0 | 60 |
| 2016 | 0 | — | 0 | 44 |
| 2017 | 0 | — | 1 | 43 |
| 2018 | 0 | — | 0 | 40 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 1 | 14 |
| 2022 | 1 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The COLDFLO™ models combine cold and compression therapies. This combination is intended to provide a temporary increase in the circulation of fluids from the treated limb, reducing minor pain and swelling. The device may also enhance healing secondary to the reduction of swelling in the limb.
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/K961425 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961425: Bio Compression Cold Flo, Single Chamber Intermittent and Multi-Chamber Sequential Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961425
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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