510(k) · Cleared
ClearedIovera System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacira Pharmaceuticals, Inc. · GXH Device, Surgical, Cryogenic
Cleared on Sep 10, 2021 as substantially equivalent to K161835 (Myoscience, Inc., 2017) after a 130-day review. Its family tree reaches back 10 generations to 1978. 2 later devices descend from it.
- Decided
- Sep 10, 2021
- Review
- 130 days
- Class
- Class II
- Product code
- GXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K781302 (1978). 15 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK781302 Neurostat, LloydSpembly Medical, Ltd. · 1978
- 6 generations between
- 3 generations backK133453 IoveraMyoscience, Inc. · 2014
- 2 generations backK142866 Myoscience iovera systemMyoscience, Inc. · 2015 · Recalled
- 1 generation backK161835 iovera systemMyoscience, Inc. · 2017
- This deviceK211334 Iovera SystemPacira Pharmaceuticals, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK220656 iovera SystemPacira Biosciences, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK243677 iovera° SystemPacira Biosciences, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK781302 Neurostat, LloydSpembly Medical, Ltd. · 1978
- 9 generations backK031482 Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM…Cryomedical Instruemts, Ltd. · 2003
- 8 generations backK050272 Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 2005
- 7 generations backK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- 6 generations backK102021 Cryo-Touch IIMyoscience, Inc. · 2010
- 5 generations backK120415 Cryo-Touch IiiMyoscience, Inc. · 2012
- 4 generations backK123516 Cryo-Touch IVMyoscience, Inc. · 2013 · Recalled
- 3 generations backK133453 IoveraMyoscience, Inc. · 2014
- 2 generations backK142866 Myoscience iovera systemMyoscience, Inc. · 2015 · Recalled
- 1 generation backK161835 iovera systemMyoscience, Inc. · 2017
- This deviceK211334 Iovera SystemPacira Pharmaceuticals, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K781302 | Neurostat, Lloyd | Spembly Medical, Ltd. | 1978 | — |
| −9 | K031482 | Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe… | Cryomedical Instruemts, Ltd. | 2003 | — |
| −8 | K050272 | Cryomedical Instruments Cryo-Pac Systems | Cryomedical Instruments, Ltd. | 2005 | — |
| −7 | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| −6 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
| −5 | K120415 | Cryo-Touch Iii | Myoscience, Inc. | 2012 | — |
| −4 | K123516 | Cryo-Touch IV | Myoscience, Inc. | 2013 | 1 |
| −3 | K133453 | Iovera | Myoscience, Inc. | 2014 | — |
| −2 | K142866 | Myoscience iovera system | Myoscience, Inc. | 2015 | 1 |
| −1 | K161835 | iovera system | Myoscience, Inc. | 2017 | — |
| 0 (this device) | K211334 | Iovera System | Pacira Pharmaceuticals, Inc. | 2021 | — |
| +1 | K220656 | iovera System | Pacira Biosciences, Inc. | 2022 | — |
| +1 | K243677 | iovera° System | Pacira Biosciences, Inc. | 2024 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K161835 | iovera systemSummary page 4…ivalent to the following currently legally marketed device: 510(k) Number Product Sponsor K161835 iovera° system Pacira Pharmaceuticals… | 2017 |
What descends from it? (2)
2 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?
- The line of descent spans 43 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K220656 (Pacira Biosciences, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K161835.
How does its category compare?
All GXH devicesGXH Device, Surgical, Cryogenic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 iovera® system 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. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera® system is not indicated for treatment of central nervous system tissue.
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/K211334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211334: Iovera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211334
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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