510(k) · Cleared
ClearedPainblocker WA5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallach Surgical Devices, Inc. · GXH Device, Surgical, Cryogenic
Cleared on Apr 30, 1986 after a 184-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.
- Decided
- Apr 30, 1986
- Review
- 184 days
- Class
- Class II
- Product code
- GXH
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 3 citing it directly.
- This deviceK854334 Painblocker WA5000Wallach Surgical Devices, Inc. · 1986
- Descendant · cites it directly · 22 of its ownK031482 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 · cites it directly · 10 of its ownK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- Descendant · 2 generations on · 9 of its ownK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- Descendant · 2 generations on · 9 of its ownK102021 Cryo-Touch IIMyoscience, Inc. · 2010
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K031482Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe, C) Cryostar…Cryomedical Instruemts, Ltd. · 2003 · cites it directly22descendants
- K050272Cryomedical Instruments Cryo-Pac SystemsCryomedical Instruments, Ltd. · 2005 · cites it directly11descendants
- K100447Myoscience Cryo-TouchMyoscience, Inc. · 2010 · cites it directly10descendants
- K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014 · 2 generations on9descendants
- K102021Cryo-Touch IIMyoscience, Inc. · 2010 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854334 | Painblocker WA5000 | Wallach Surgical Devices, Inc. | 1986 | — |
| +1 | 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 | — |
| +1 | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| +2 | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014 | — |
| +2 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (23)
See all 233 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?
- Of its descendants, K031482 (Cryomedical Instruemts, Ltd., 2003) has gone furthest, with 22 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.
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 | — |
https://510kreport.com/device/K854334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K854334: Painblocker WA5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854334
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026