510(k) · Cleared
ClearedMyoscience Cryo-Touch
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 Jun 25, 2010 as substantially equivalent to K083493 (Myoscience, Inc., 2009) and 3 other predicates after a 128-day review. Its family tree reaches back 3 generations to 1978. 10 later devices descend from it.
- Decided
- Jun 25, 2010
- Review
- 128 days
- Class
- Class II
- Product code
- GXH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K781302 (1978). 8 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK781302 Neurostat, LloydSpembly Medical, Ltd. · 1978
- 2 generations backK031482 Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM…Cryomedical Instruemts, Ltd. · 2003
- 1 generation backK050272 Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 2005
- This deviceK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- Descendant · cites it directly · 9 of its ownK102021 Cryo-Touch IIMyoscience, Inc. · 2010
- Descendant · 2 generations on · 8 of its ownK120415 Cryo-Touch IiiMyoscience, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK123516 Cryo-Touch IVMyoscience, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 6 of its ownK133453 IoveraMyoscience, Inc. · 2014
- Descendant · 4 generations on · 5 of its ownK142866 Myoscience iovera systemMyoscience, Inc. · 2015 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K102021Cryo-Touch IIMyoscience, Inc. · 2010 · cites it directly9descendants
- K120415Cryo-Touch IiiMyoscience, Inc. · 2012 · 2 generations on8descendants
- K123516Cryo-Touch IVMyoscience, Inc. · 2013 · 2 generations on7descendants
- K133453IoveraMyoscience, Inc. · 2014 · 3 generations on6descendants
- K142866Myoscience iovera systemMyoscience, Inc. · 2015 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K781302 | Neurostat, Lloyd | Spembly Medical, Ltd. | 1978 | — |
| −2 | K031482 | Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe… | Cryomedical Instruemts, Ltd. | 2003 | — |
| −1 | K050272 | Cryomedical Instruments Cryo-Pac Systems | Cryomedical Instruments, Ltd. | 2005 | — |
| 0 (this device) | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| +1 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
| +2 | K120415 | Cryo-Touch Iii | Myoscience, Inc. | 2012 | — |
| +2 | K123516 | Cryo-Touch IV | Myoscience, Inc. | 2013 | 1 |
| +3 | K133453 | Iovera | Myoscience, Inc. | 2014 | — |
| +4 | K142866 | Myoscience iovera system | Myoscience, Inc. | 2015 | 1 |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K083493 | Myoscience Cryo-TouchSummary page 1…e Cryo-Touch is substantially equivalent to the following currently legally marked devices: _510(k) Number Product - Sponsor _K083493 Cryo-Touchn MyoScience, Inc _K050272 Cryo-PaC"~ Syste… | 2009 |
| * | K050272 | Cryomedical Instruments Cryo-Pac SystemsSummary page 1…vices: _510(k) Number Product - Sponsor _K083493 Cryo-Touchn MyoScience, Inc _K050272 Cryo-PaC"~ System Cryomedical Instruments 1K854334 Painiblock… | 2005 |
| * | K854334 | Painblocker WA5000Summary page 1…Cryo-Touchn MyoScience, Inc _K050272 Cryo-PaC"~ System Cryomedical Instruments 1K854334 Painiblocker WA 5000 Wallach Surgical Devices 1K831963 Cryomedic… | 1986 |
| * | K831963 | Cryomedics NeurostatSummary page 1…Cryo-PaC"~ System Cryomedical Instruments 1K854334 Painiblocker WA 5000 Wallach Surgical Devices 1K831963 Cryomedics Neurostat Spembly Medical Ltd b. Date Summary Prepared June 21, 2010 c. Desc… | 1983 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102021 | Cryo-Touch II | 2010 | 9 |
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 32 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K102021 (Myoscience, Inc., 2010) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K083493.
How does its category compare?
All GXH devicesGXH Device, Surgical, Cryogenic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 is 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 is not indicated for treatment of central nervous system tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100447: Myoscience Cryo-Touch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100447
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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