510(k) · Cleared
ClearedPortable Therapeutix Squid Active Cold Compression Device and Cold Pack for Otc Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portable Therapeutix · IRP Massager, Powered Inflatable Tube
Cleared on Mar 11, 2014 as substantially equivalent to K123829 (Portable Therapeutix, LLC, 2013) after a 118-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Mar 11, 2014
- Review
- 118 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030437 (2003). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK030437 Relaxor Perfect Touch Air Massaging SystemSalton, Inc. · 2003
- 1 generation backK123829 Portable Therapeutix Squid Active Cold Compression Device and Cold…Portable Therapeutix, LLC · 2013
- This deviceK133483 Portable Therapeutix Squid Active Cold Compression Device and Cold…Portable Therapeutix · 2014
- Descendant · cites it directly · 0 of its ownK230524 Cold Compression Wrap ProChengdu Cryo-Push Medical Technology Co.,Ltd · 2024
Most influential descendants
Showing 1 of 1 · See all- K230524Cold Compression Wrap ProChengdu Cryo-Push Medical Technology Co.,Ltd · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030437 | Relaxor Perfect Touch Air Massaging System | Salton, Inc. | 2003 | — |
| −1 | K123829 | Portable Therapeutix Squid Active Cold Compression Device and Cold Pack | Portable Therapeutix, LLC | 2013 | — |
| 0 (this device) | K133483 | Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for… | Portable Therapeutix | 2014 | — |
| +1 | K230524 | Cold Compression Wrap Pro | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 IRP? 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 IRP device
- #1 K193354 Air Compression Therapy Devicescore 28.6 · 8 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 |
|---|---|---|---|
| * | K123829 | Portable Therapeutix Squid Active Cold Compression Device and Cold PackSummary page 1…s: 21 CFR 890.5650, Class 11 and Class 21 CFR 890.5700, Class I15 10(k) exempt Product Codes: IRP; IME C) Predicates: K123829 Portable Therapeutix Squid Active Cold Compression Cold Pack D) Device Description: The Squid Activ… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230524 | Cold Compression Wrap Pro | 2024 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K230524 (Chengdu Cryo-Push Medical Technology Co.,Ltd, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · IRP
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IRP
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IRP
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IRP
10in 2025
MAUDE reports naming product code IRP, 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 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 5 |
| 2011 | 3 | 164 | 1 | 3 |
| 2012 | 5 | 116 | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 113 | 0 | 0 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 4 | 170 | 2 | 0 |
| 2018 | 3 | 80 | 0 | 0 |
| 2019 | 10 | 83 | 0 | 0 |
| 2020 | 9 | 150 | 0 | 1 |
| 2021 | 19 | 140 | 0 | 0 |
| 2022 | 14 | 97 | 0 | 1 |
| 2023 | 10 | 143 | 0 | 0 |
| 2024 | 12 | 115 | 0 | 4 |
| 2025 | 13 | 141 | 0 | 10 |
| 2026 | 12 | 172 | 0 | — |
What is it indicated for?
The Squid Active Cold Compression device and Cold Pack for OTC use is indicated for the temporary relief of minor muscle aches and pains.
The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133483 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133483: Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for Otc Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133483
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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