510(k) · Cleared
ClearedCry-Ac®, Cry-Ac-3®, Cry-Baby
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brymill Cryogenic Systems · GEH Unit, Cryosurgical, Accessories
Cleared on Mar 25, 2020 as substantially equivalent to K031117 (Galil Medical, Ltd., 2003) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Mar 25, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010991 (2001). 6 ancestors in all, the oldest K935010 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 3 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 2 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 1 generation backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- This deviceK193619 Cry-Ac®, Cry-Ac-3®, Cry-BabyBrymill Cryogenic Systems · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −3 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −2 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −1 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| 0 (this device) | K193619 | Cry-Ac®, Cry-Ac-3®, Cry-Baby | Brymill Cryogenic Systems | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 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? (4)
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 |
|---|---|---|---|
| * | K031117 | Seednet System and Seednetgold SystemSummary page 4…800 and Accessories, Pre-Amendments Devices, Brymill Corporation • Secondary predicates o SeedNet™ System and SeedNetGold™ System, K031117, Galil Medical Ltd. o CryoPro® Mini and CryoPro® Maxi, K982280, Cortex Technology ApS o Wallach Ultra… | 2003 |
| * | K982280 | Cryopro Maxi and Cryopro MiniSummary page 4…on • Secondary predicates o SeedNet™ System and SeedNetGold™ System, K031117, Galil Medical Ltd. o CryoPro® Mini and CryoPro® Maxi, K982280, Cortex Technology ApS o Wallach Ultra Freeze, K935010, Wallach Surgical Devices Inc. IV. Device Descriptio… | 1998 |
| * | K935010 | Wallach Ultra FreezeSummary page 4…nd SeedNetGold™ System, K031117, Galil Medical Ltd. o CryoPro® Mini and CryoPro® Maxi, K982280, Cortex Technology ApS o Wallach Ultra Freeze, K935010, Wallach Surgical Devices Inc. IV. Device Description The Cry-Ac® Cryosurgical Devices (Cry-Ac®, Cry-Ac-3®, and Cry-Baby… | 1994 |
| * | — | Cry-Ac B-700 and B-800 and Accessories Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K031117.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 Cry-Ac® Cryosurgical Devices and Accessories are intended for use as cryosurgical tools in the field of dermatology. The Cry-Ac® Cryosurgical Devices and Accessories are indicated for:
Ablation or freezing of skin cancers and other cutaneous disorders
Destruction of skin tags, warts or lesions, angiomas, sebaceous hyperplasia, basal cell carcinoma, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, perianal condylomata, and palliation of tumors of the skin
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/K193619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193619: Cry-Ac®, Cry-Ac-3®, Cry-Baby.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193619
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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