510(k) · Cleared
ClearedCryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe, C) Cryostar 2MM Cryoprobe, D) Convenience
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryomedical Instruemts, Ltd. · GXH Device, Surgical, Cryogenic
Cleared on Jul 10, 2003 as substantially equivalent to K781302 (Spembly Medical, Ltd., 1978) and 2 other predicates after a 59-day review. Its family tree reaches back 1 generation to 1978. 22 later devices descend from it.
- Decided
- Jul 10, 2003
- Review
- 59 days
- Class
- Class II
- Product code
- GXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K781302 (1978). 3 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK781302 Neurostat, LloydSpembly Medical, Ltd. · 1978
- This deviceK031482 Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM…Cryomedical Instruemts, Ltd. · 2003
- Descendant · cites it directly · 11 of its ownK050272 Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 2005
- Descendant · 2 generations on · 10 of its ownK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- Descendant · cites it directly · 9 of its ownK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- Descendant · 3 generations on · 9 of its ownK102021 Cryo-Touch IIMyoscience, Inc. · 2010
- Descendant · 4 generations on · 8 of its ownK120415 Cryo-Touch IiiMyoscience, Inc. · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K050272Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 2005 · cites it directly11descendants
- K100447Myoscience Cryo-TouchMyoscience, Inc. · 2010 · 2 generations on10descendants
- K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014 · cites it directly9descendants
- K102021Cryo-Touch IIMyoscience, Inc. · 2010 · 3 generations on9descendants
- K120415Cryo-Touch IiiMyoscience, Inc. · 2012 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781302 | Neurostat, Lloyd | Spembly Medical, Ltd. | 1978 | — |
| 0 (this device) | 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 | — |
| +2 | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| +1 | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014 | — |
| +3 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
| +4 | K120415 | Cryo-Touch Iii | Myoscience, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K781302 | Neurostat, LloydSummary page 1…and assigned the Product Code GXI'1 Predicate Devices T'he components of the CryoStar™ system are substantially equivalent to the following legally marketed devices: K781302 Spembly Iloyd Neurostat K831963 Cryomedics Neurostat K854334 Wallach Painblocker WA5000 T'his statement is based on the similari… | 1978 |
| * | K831963 | Cryomedics NeurostatSummary page 1…XI'1 Predicate Devices T'he components of the CryoStar™ system are substantially equivalent to the following legally marketed devices: K781302 Spembly Iloyd Neurostat K831963 Cryomedics Neurostat K854334 Wallach Painblocker WA5000 T'his statement is based on the similarity of the subject device to the… | 1983 |
| * | K854334 | Painblocker WA5000Summary page 1…components of the CryoStar™ system are substantially equivalent to the following legally marketed devices: K781302 Spembly Iloyd Neurostat K831963 Cryomedics Neurostat K854334 Wallach Painblocker WA5000 T'his statement is based on the similarity of the subject device to the predicate devices in intended… | 1986 |
What descends from it? (22)
See all 222 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?
How does its category compare?
All GXH devicesGXH Device, Surgical, Cryogenic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CryoStar™ system is a cryoanalgesia device intended for use in blocking pain by temporarily ablating the peripheral nerves.
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/K031482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031482: Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe, C) Cryostar 2MM Cryoprobe, D) Convenience.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031482
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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