510(k) · Cleared
Recalled · Class II · 2013Cryo-Touch IV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myoscience, Inc. · GXH Device, Surgical, Cryogenic
Cleared on Jan 10, 2013 as substantially equivalent to K102021 (Myoscience, Inc., 2010) and 1 other predicate after a 57-day review. Its family tree reaches back 6 generations to 1978. 7 later devices descend from it. It has been recalled once.
- Decided
- Jan 10, 2013
- Review
- 57 days
- Class
- Class II
- Product code
- GXH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K781302 (1978). 11 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK781302 Neurostat, LloydSpembly Medical, Ltd. · 1978
- 5 generations backK031482 Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM…Cryomedical Instruemts, Ltd. · 2003
- 4 generations backK050272 Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 2005
- 3 generations backK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- 2 generations backK102021 Cryo-Touch IIMyoscience, Inc. · 2010
- 1 generation backK120415 Cryo-Touch IiiMyoscience, Inc. · 2012
- This deviceK123516 Cryo-Touch IVMyoscience, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK133453 IoveraMyoscience, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK142866 Myoscience iovera systemMyoscience, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 4 of its ownK161835 iovera systemMyoscience, Inc. · 2017
- Descendant · 4 generations on · 2 of its ownK211334 Iovera SystemPacira Pharmaceuticals, Inc. · 2021
- Descendant · 4 generations on · 2 of its ownK173763 iovera systemMyoscience, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133453IoveraMyoscience, Inc. · 2014 · cites it directly6descendants
- K142866Myoscience iovera systemMyoscience, Inc. · 2015 · 2 generations on5descendants
- K161835iovera systemMyoscience, Inc. · 2017 · 3 generations on4descendants
- K211334Iovera SystemPacira Pharmaceuticals, Inc. · 2021 · 4 generations on2descendants
- K173763iovera systemMyoscience, Inc. · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K781302 | Neurostat, Lloyd | Spembly Medical, Ltd. | 1978 | — |
| −5 | K031482 | Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe… | Cryomedical Instruemts, Ltd. | 2003 | — |
| −4 | K050272 | Cryomedical Instruments Cryo-Pac Systems | Cryomedical Instruments, Ltd. | 2005 | — |
| −3 | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| −2 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
| −1 | K120415 | Cryo-Touch Iii | Myoscience, Inc. | 2012 | — |
| 0 (this device) | K123516 | Cryo-Touch IV | Myoscience, Inc. | 2013 | — |
| +1 | K133453 | Iovera | Myoscience, Inc. | 2014 | — |
| +2 | K142866 | Myoscience iovera system | Myoscience, Inc. | 2015 | 1 |
| +3 | K161835 | iovera system | Myoscience, Inc. | 2017 | — |
| +4 | K211334 | Iovera System | Pacira Pharmaceuticals, Inc. | 2021 | — |
| +4 | K173763 | iovera system | Myoscience, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 GXH? 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 GXH device
- #1 K250371 cryoICE cryoXT cryoablation probe (cryoXT)score 13.9 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K102021 | Cryo-Touch IISummary page 1…yo-Touch IVis substantially equivalent to the following currently legally marketed devices: 510(k) Number Product ISponsor K102021 Cryo-Touch 11 Myoscience, Inc K120415 Cryo-Touch III… | 2010 |
| * | K120415 | Cryo-Touch IiiSummary page 1…devices: 510(k) Number Product ISponsor K102021 Cryo-Touch 11 Myoscience, Inc K120415 Cryo-Touch III Myoscience, Inc b. Date Summary Prepared November 6, 2012 c. Descriptio… | 2012 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133453 | Iovera | 2014 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 21, 2013 | Class II | Z-1781-2013 | Labeling mix-ups | The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K133453 (Myoscience, Inc., 2014) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K102021.
How does its category compare?
All GXH devicesGXH Device, Surgical, Cryogenic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GXH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXH
52in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXH
No recall names GXH since 2007.
Adverse event reports per year · GXH
5in 2025
MAUDE reports naming product code GXH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 3 | 52 | 0 | 14 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 6 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Myoscience Cryo-Touch IV is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV is not indicated for treatment of central nervous system tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123516: Cryo-Touch IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123516
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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