510(k) · Cleared
ClearedCMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryomedical Sciences, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Jul 17, 1998 after a 147-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.
- Decided
- Jul 17, 1998
- Review
- 147 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 1 citing it directly.
- This deviceK980668 CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790Cryomedical Sciences, Inc. · 1998
- Descendant · cites it directly · 31 of its ownK011988 Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001
- Descendant · 2 generations on · 30 of its ownK013901 Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001
- Descendant · 3 generations on · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- Descendant · 2 generations on · 22 of its ownK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- Descendant · 3 generations on · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K011988Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001 · cites it directly31descendants
- K013901Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001 · 2 generations on30descendants
- K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · 3 generations on23descendants
- K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc. · 2004 · 2 generations on22descendants
- K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980668 | CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790 | Cryomedical Sciences, Inc. | 1998 | — |
| +1 | K011988 | Surgical Lightstic 180, Model 180 L, Model 180 C | Cardiofocus, Inc. | 2001 | — |
| +2 | K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) | Cardiofocus, Inc. | 2001 | — |
| +3 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| +2 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| +3 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | ENDOcare’s CRYOcare System Named without a submission number | |
| * | — | CMS AccuProbe® Systems Named without a submission number | |
| * | — | CMS Cryo-lite™ System Named without a submission number |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011988 | Surgical Lightstic 180, Model 180 L, Model 180 C | 2001 | 31 |
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, K011988 (Cardiofocus, Inc., 2001) has gone furthest, with 31 descendants of its own.
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?
Depending on the cryogen used, the following are indications for use: Liquid Nitrogen: For use as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT. May be used to ablate prostatic tissue. May be used for the ablation of prostatic tissue in cases of prosfofe cancer and benign prostatic hyperplasia. May be used for ablation…
Read the full statement (310 words)
Depending on the cryogen used, the following are indications for use:
Liquid Nitrogen:
For use as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT.
May be used to ablate prostatic tissue.
May be used for the ablation of prostatic tissue in cases of prosfofe cancer and benign prostatic hyperplasia.
May be used for ablation of cancerous or malignant tissue.
May be used for ablation of benign tumors.
May be used for palliative intervention.
May be used for ablation or freezing of skin cancers and other cutaneous disorders.
May be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.
May be used for ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofioromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.
May be used for the destruction of warts or lesions,
May be used for the palliation of tumors of the oral cavity, rectum, and skin.
May be used for ablation of arrhythmic cardiac tissue.
May be used for the ablation of benign or malignant growths of the anus and rectum.
May be used for the ablation of hemorrhoids.
Nitrous Oxide:
For use as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and veterinary medicine.
Carbon Dioxide:
For used as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery.
Argon and Krypton:
For use as a cryosurgical tool in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastases, skin Jlesions, warts and prostate tissue.
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/K980668 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980668: CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980668
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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