510(k) Report

510(k) · Cleared

Cleared

CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722

K980670510(k) TraditionalCleared Jul 17, 1998147-day reviewClass II21 CFR 878.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Decided
Jul 17, 1998
Review
147 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K980670Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

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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.

TypeNumberDeviceApplicantDecidedRecalls
*—Cryo-lite™ System
Named without a submission number
—
*—AccuProbe® 600 Series
Named without a submission number
—
*—Cabot Medical's Cryomedics MT700
Named without a submission number
—
*—Erbe Erbokryo CA
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.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEH

10in 2025

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

What is it indicated for?

The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721and 722, depending on the cryogen selected, are intended to be used: Liquid Nitrogen: 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; to ablate prostatic tissue; for the ablation of prostatic tissue in cases of prostate cancer and benign prostatic hyperplasia…

Read the full statement (272 words)

The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721and 722, depending on the cryogen selected, are intended to be used:

Liquid Nitrogen:

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;

to ablate prostatic tissue;

for the ablation of prostatic tissue in cases of prostate cancer and benign prostatic hyperplasia;

for ablation of cancerous or malignant tissue;

for ablation of benign tumors;

for palliative intervention;

for ablation or freezing of skin cancers and other cutaneous disorders;

for the ablation of malignant neoplasia or benign dysplasia of the female genitalia;

for ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid and canthus areaq, vlcerated basal cell tumors, dermatofibromas, 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;

for the destruction of warts or lesions;

for the palliation of tumors of the oral cavity, rectum, and skin;.

for ablation of arrhythmic cardiac tissue;

for the ablation of benign or malignant growths of the anus and rectum;

for the ablation of hemorrhoids;

Nitrous Oxide:

as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, general surgery, and urology;

Carbon Dioxide:

as a tool in the destruction of unwanted tissue in the fields of germotology, gynecology, and general surgery;

Argon and Krypton:

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 lesions, 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.

Cite this page

510(k) Report. “K980670: CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980670

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026