510(k) · Cleared
ClearedIovera
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 Mar 24, 2014 as substantially equivalent to K123516 (Myoscience, Inc., 2013) after a 132-day review. Its family tree reaches back 7 generations to 1978. 6 later devices descend from it.
- Decided
- Mar 24, 2014
- Review
- 132 days
- Class
- Class II
- Product code
- GXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K781302 (1978). 12 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK781302 Neurostat, LloydSpembly Medical, Ltd. · 1978
- 6 generations backK031482 Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM…Cryomedical Instruemts, Ltd. · 2003
- 5 generations backK050272 Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 2005
- 4 generations backK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- 3 generations backK102021 Cryo-Touch IIMyoscience, Inc. · 2010
- 2 generations backK120415 Cryo-Touch IiiMyoscience, Inc. · 2012
- 1 generation backK123516 Cryo-Touch IVMyoscience, Inc. · 2013 · Recalled
- This deviceK133453 IoveraMyoscience, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK142866 Myoscience iovera systemMyoscience, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 4 of its ownK161835 iovera systemMyoscience, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK211334 Iovera SystemPacira Pharmaceuticals, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK173763 iovera systemMyoscience, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK220656 iovera SystemPacira Biosciences, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142866Myoscience iovera systemMyoscience, Inc. · 2015 · cites it directly5descendants
- K161835iovera systemMyoscience, Inc. · 2017 · 2 generations on4descendants
- K211334Iovera SystemPacira Pharmaceuticals, Inc. · 2021 · 3 generations on2descendants
- K173763iovera systemMyoscience, Inc. · 2018 · 3 generations on2descendants
- K220656iovera SystemPacira Biosciences, Inc. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K781302 | Neurostat, Lloyd | Spembly Medical, Ltd. | 1978 | — |
| −6 | K031482 | Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe… | Cryomedical Instruemts, Ltd. | 2003 | — |
| −5 | K050272 | Cryomedical Instruments Cryo-Pac Systems | Cryomedical Instruments, Ltd. | 2005 | — |
| −4 | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| −3 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
| −2 | K120415 | Cryo-Touch Iii | Myoscience, Inc. | 2012 | — |
| −1 | K123516 | Cryo-Touch IV | Myoscience, Inc. | 2013 | 1 |
| 0 (this device) | K133453 | Iovera | Myoscience, Inc. | 2014 | — |
| +1 | K142866 | Myoscience iovera system | Myoscience, Inc. | 2015 | 1 |
| +2 | K161835 | iovera system | Myoscience, Inc. | 2017 | — |
| +3 | K211334 | Iovera System | Pacira Pharmaceuticals, Inc. | 2021 | — |
| +3 | K173763 | iovera system | Myoscience, Inc. | 2018 | — |
| +4 | K220656 | iovera System | Pacira Biosciences, Inc. | 2022 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K123516 | Cryo-Touch IVSummary page 1…e iovera0 device issubstantially equivalent to the following currently leally marketed devices: 510(k) Number Product Sponsor K1 23516 Cryo-Touch IV myoscience, Inc b. Date Summary Prepared November 07, 2013 c. Des… | 2013 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142866 | Myoscience iovera system | 2015 | 5 |
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 36 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K142866 (Myoscience, Inc., 2015) has gone furthest, with 5 descendants of its own.
How does its category compare?
All GXH devicesGXH Device, Surgical, Cryogenic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 iovera0 device 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 iovera0 device is not indicated for treatment of central nervous system tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133453: Iovera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133453
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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