510(k) · Cleared
ClearedArtrotherm Cryotherapy and Thernotherapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormed GmbH · ILO Pack, Hot Or Cold, Water Circulating
Cleared on Aug 29, 1997 after a 273-day review. The FDA summary names its predicate without a number. 117 later devices descend from it.
- Decided
- Aug 29, 1997
- Review
- 273 days
- Class
- Class II
- Product code
- ILO
- Recalls
- None
- Predicates
- 0
117 later devices descend from it, 2 citing it directly.
- This deviceK964799 Artrotherm Cryotherapy and ThernotherapyOrmed GmbH · 1997
- Descendant · cites it directly · 63 of its ownK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- Descendant · cites it directly · 52 of its ownK061866 Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006
- Descendant · 2 generations on · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
- Descendant · 2 generations on · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- Descendant · 3 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K023231Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003 · cites it directly63descendants
- K061866Nanotherm, Vascutherm and Prothermo Therapy WrapsThermotek, Inc. · 2006 · cites it directly52descendants
- K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · 2 generations on35descendants
- K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · 2 generations on34descendants
- K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · 3 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964799 | Artrotherm Cryotherapy and Thernotherapy | Ormed GmbH | 1997 | — |
| +1 | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| +1 | K061866 | Nanotherm, Vascutherm and Prothermo Therapy Wraps | Thermotek, Inc. | 2006 | — |
| +2 | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
| +2 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| +3 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 12 | 0 |
| 2020 | 10 | 0 |
| 2021 | 14 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 10 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 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? (2)
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 |
|---|---|---|---|
| * | — | TTU-100 by Danninger Medical Technology, Inc. Named without a submission number | |
| * | — | Hot/Ice® HE500/A by ThermoTemp, Inc. Named without a submission number |
What descends from it? (117)
See all 1172 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K023231 (Mediseb, Ltd., 2003) has gone furthest, with 63 descendants of its own.
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?
1. Localized thermal therapy (hot or cold) for post traumatic and
post surgical medical and/or surgical conditions.
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/K964799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964799: Artrotherm Cryotherapy and Thernotherapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964799
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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