510(k) · Cleared
Recalled · 2007Cryo-Hit, Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galil Medical, Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on Oct 30, 2001 as substantially equivalent to K993965 (Galil Medical, Ltd., 2000) after an 88-day review. Its family tree reaches back 3 generations to 1998. 29 later devices descend from it. It has been recalled once.
- Decided
- Oct 30, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980913 (1998). 29 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK980913 Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Galil Medical, Ltd. · 1998
- 2 generations backK991517 Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Galil Medical, Ltd. · 1999
- 1 generation backK993965 Cryo-HitGalil Medical, Ltd. · 2000
- This deviceK012497 Cryo-Hit, Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1Galil Medical, Ltd. · 2001
- Descendant · cites it directly · 28 of its ownK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- Descendant · 2 generations on · 22 of its ownK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 20 of its ownK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
- Descendant · 2 generations on · 15 of its ownK113860 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 13 of its ownK152133 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate…Galil Medical, Ltd. · 2015 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K060390Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · cites it directly28descendants
- K121251Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · 2 generations on22descendants
- K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014 · 3 generations on20descendants
- K113860Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2012 · 2 generations on15descendants
- K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…Galil Medical, Ltd. · 2015 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980913 | Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 | Galil Medical, Ltd. | 1998 | — |
| −2 | K991517 | Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 | Galil Medical, Ltd. | 1999 | — |
| −1 | K993965 | Cryo-Hit | Galil Medical, Ltd. | 2000 | — |
| 0 (this device) | K012497 | Cryo-Hit, Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1 | Galil Medical, Ltd. | 2001 | — |
| +1 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| +2 | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack | Galil Medical, Ltd. | 2012 | 1 |
| +3 | K140584 | Icerod CX Cryoablation Needle | Galil Medical, Ltd. | 2014 | — |
| +2 | K113860 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2012 | 2 |
| +3 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit… | Galil Medical, Ltd. | 2015 | 18 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 GEH? 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 GEH device
- #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 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 |
|---|---|---|---|
| * | K993965 | Cryo-HitSummary page 3…osurgical procedure. Technological Characteristics: Tflé Galil Medical’s Cryo-Hit™ System for Cryoanalgesia is a modification of Galil Medical LTD’s cleared Cryo-Hit™ (K993965). The modified Cryo-Hit™ System is the exact same device as the Cryo-Hit™ except for the addition of the 4.5 mm surface probe.… | 2000 |
| * | — | Cryomedics, Neurostat Named without a submission number | |
| * | — | Spembly Lloyd Neurostat Named without a submission number |
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | 2006 | 28 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2007 | Not classified | Z-1698-2008 | Process control | The warming catheter was manufactured with the inlet and outlet tubes switched. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K060390 (Galil Medical, Ltd., 2006) has gone furthest, with 28 descendants of its own.
- 2 other devices also cite its predicate K993965.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, 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 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
What is it indicated for?
The CRYO-HIT™ System is intended for cryogenic destruction of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin…
Read the full statement (251 words)
The CRYO-HIT™ System is intended for cryogenic destruction of tissue during surgical procedures.
It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology.
The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The CRYO-HIT™ System has the following specific indications:
Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia “BPH”)
Oncology (ablation of cancerous or malignant tissue and benign tumors and palliative intervention)
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin)
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.)
ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)
Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions)
Proctology (ablation of benign or malignant growths of the anus or rectum and hemorrhoids)
The CRYO-HIT™ System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.
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/K012497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012497: Cryo-Hit, Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012497
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026