510(k) · Cleared
ClearedCryomedical Instruments Cryo-Pac Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryomedical Instruments, Ltd. · GXH Device, Surgical, Cryogenic
Cleared on Mar 24, 2005 as substantially equivalent to K031482 (Cryomedical Instruemts, Ltd., 2003) and 2 other predicates after a 48-day review. Its family tree reaches back 2 generations to 1978. 11 later devices descend from it.
- Decided
- Mar 24, 2005
- Review
- 48 days
- Class
- Class II
- Product code
- GXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K781302 (1978). 4 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK781302 Neurostat, LloydSpembly Medical, Ltd. · 1978
- 1 generation backK031482 Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM…Cryomedical Instruemts, Ltd. · 2003
- This deviceK050272 Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 2005
- Descendant · cites it directly · 10 of its ownK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- Descendant · 2 generations on · 9 of its ownK102021 Cryo-Touch IIMyoscience, Inc. · 2010
- Descendant · 3 generations on · 8 of its ownK120415 Cryo-Touch IiiMyoscience, Inc. · 2012
- Descendant · 3 generations on · 7 of its ownK123516 Cryo-Touch IVMyoscience, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 6 of its ownK133453 IoveraMyoscience, Inc. · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K100447Myoscience Cryo-TouchMyoscience, Inc. · 2010 · cites it directly10descendants
- K102021Cryo-Touch IIMyoscience, Inc. · 2010 · 2 generations on9descendants
- K120415Cryo-Touch IiiMyoscience, Inc. · 2012 · 3 generations on8descendants
- K123516Cryo-Touch IVMyoscience, Inc. · 2013 · 3 generations on7descendants
- K133453IoveraMyoscience, Inc. · 2014 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K781302 | Neurostat, Lloyd | Spembly Medical, Ltd. | 1978 | — |
| −1 | K031482 | Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe… | Cryomedical Instruemts, Ltd. | 2003 | — |
| 0 (this device) | K050272 | Cryomedical Instruments Cryo-Pac Systems | Cryomedical Instruments, Ltd. | 2005 | — |
| +1 | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| +2 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
| +3 | K120415 | Cryo-Touch Iii | Myoscience, Inc. | 2012 | — |
| +3 | K123516 | Cryo-Touch IV | Myoscience, Inc. | 2013 | 1 |
| +4 | K133453 | Iovera | Myoscience, Inc. | 2014 | — |
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 |
|---|---|---|
| 2010 | 2 | 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? (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 |
|---|---|---|---|
| * | K031482 | Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe, C) Cryostar…Summary page 1…ct Code GXH 3 Predicate Devices The components of the Cryo-PaCTM system are substantially equivalent to the following legally marketed devices: K031482 Cryomedical Instruments CryoStar T M K781302 Spembly Lloyd Neurostat® K854334 W… | 2003 |
| * | K781302 | Neurostat, LloydSummary page 1…o-PaCTM system are substantially equivalent to the following legally marketed devices: K031482 Cryomedical Instruments CryoStar T M K781302 Spembly Lloyd Neurostat® K854334 Wallach Painblocker WA5000 This statement is based on the simi… | 1978 |
| * | K854334 | Painblocker WA5000Summary page 1…following legally marketed devices: K031482 Cryomedical Instruments CryoStar T M K781302 Spembly Lloyd Neurostat® K854334 Wallach Painblocker WA5000 This statement is based on the similarity of the subject device to the predicate devi… | 1986 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100447 | Myoscience Cryo-Touch | 2010 | 10 |
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 27 years and passes through 3 companies; a new generation was cleared every 24.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K100447 (Myoscience, Inc., 2010) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K031482.
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 Cryo-PaCTM systems are a series of cryoanalgesia devices intended for use in blocking pain by temporarily ablating the peripheral nerves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050272: Cryomedical Instruments Cryo-Pac Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050272
Report an extraction error
Are you the manufacturer?
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