510(k) · Cleared
Clearediovera° System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacira Biosciences, Inc. · GXH Device, Surgical, Cryogenic
Cleared on Dec 26, 2024 as substantially equivalent to K220656 (Pacira Biosciences, Inc., 2022) and 1 other predicate after a 29-day review. Its family tree reaches back 12 generations to 1978. 1 of the 33 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 26, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- GXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K781302 (1978). 32 ancestors in all. No later device cites it as a predicate yet. 1 of the 33 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK781302 Neurostat, LloydSpembly Medical, Ltd. · 1978
- 8 generations between
- 3 generations backK161835 iovera systemMyoscience, Inc. · 2017
- 2 generations backK173763 iovera systemMyoscience, Inc. · 2018
- 1 generation backK220656 iovera SystemPacira Biosciences, Inc. · 2022
- This deviceK243677 iovera° SystemPacira Biosciences, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK781302 Neurostat, LloydSpembly Medical, Ltd. · 1978
- 11 generations backK031482 Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM…Cryomedical Instruemts, Ltd. · 2003
- 10 generations backK050272 Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 2005
- 9 generations backK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- 8 generations backK102021 Cryo-Touch IIMyoscience, Inc. · 2010
- 7 generations backK120415 Cryo-Touch IiiMyoscience, Inc. · 2012
- 6 generations backK123516 Cryo-Touch IVMyoscience, Inc. · 2013 · Recalled
- 5 generations backK133453 IoveraMyoscience, Inc. · 2014
- 4 generations backK142866 Myoscience iovera systemMyoscience, Inc. · 2015 · Recalled
- 3 generations backK161835 iovera systemMyoscience, Inc. · 2017
- 2 generations backK173763 iovera systemMyoscience, Inc. · 2018
- 1 generation backK220656 iovera SystemPacira Biosciences, Inc. · 2022
- This deviceK243677 iovera° SystemPacira Biosciences, Inc. · 2024
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an8 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K781302 | Neurostat, Lloyd | Spembly Medical, Ltd. | 1978 | — |
| −11 | K031482 | Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe… | Cryomedical Instruemts, Ltd. | 2003 | — |
| −10 | K050272 | Cryomedical Instruments Cryo-Pac Systems | Cryomedical Instruments, Ltd. | 2005 | — |
| −9 | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| −8 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
| −7 | K120415 | Cryo-Touch Iii | Myoscience, Inc. | 2012 | — |
| −6 | K123516 | Cryo-Touch IV | Myoscience, Inc. | 2013 | 1 |
| −5 | K133453 | Iovera | Myoscience, Inc. | 2014 | — |
| −4 | K142866 | Myoscience iovera system | Myoscience, Inc. | 2015 | 1 |
| −3 | K161835 | iovera system | Myoscience, Inc. | 2017 | — |
| −2 | K173763 | iovera system | Myoscience, Inc. | 2018 | — |
| −1 | K220656 | iovera System | Pacira Biosciences, Inc. | 2022 | — |
| 0 (this device) | K243677 | iovera° System | Pacira Biosciences, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1983 | 2 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2021 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K220656 | iovera SystemSummary page 5…l Nerve Stimulator Regulation No.: 21 CFR Part 882.4250 and 874.1820 Product Code: GXH, ETN Predicate Device: ioverao System K220656 and K211334 Owner/Submitter: Pacira Pharmaceuticals, Inc. 10410 Science Center Drive… | 2022 |
| * | K211334 | Iovera SystemSummary page 5…ulator Regulation No.: 21 CFR Part 882.4250 and 874.1820 Product Code: GXH, ETN Predicate Device: ioverao System K220656 and K211334 Owner/Submitter: Pacira Pharmaceuticals, Inc. 10410 Science Center Drive, Building A… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 8 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 46 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 32 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All GXH devicesGXH Device, Surgical, Cryogenic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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.
When stimulation compatible components are used, the iovera® System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.
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/K243677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243677: 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/K243677
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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