510(k) Report

510(k) · Cleared

Cleared

Polar Wand

K021387510(k) TraditionalCleared Jul 31, 200290-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

Chek-Med Systems · GEH Unit, Cryosurgical, Accessories

Cleared on Jul 31, 2002 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.

Decided
Jul 31, 2002
Review
90 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
0

12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2016: 3 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK021387 Polar WandChek-Med Systems · 2002
  2. Descendant · cites it directly · 11 of its ownK101825 Cryoballoon Ablation SystemC2 Therapeutics · 2010
  3. Descendant · 2 generations on · 10 of its ownK131523 Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · Recalled
  4. Descendant · 3 generations on · 8 of its ownK151054 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe…C2 Therapeutics, Inc. · 2015
  5. Descendant · 3 generations on · 6 of its ownK152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System…C2 Therapeutics, Inc. · 2016 · Recalled
  6. Descendant · 4 generations on · 5 of its ownK161202 C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2010: 12013: 12015: 12016: 32017: 12018: 12019: 12020: 12021: 12024: 1
2010high 3 (2016) · low 0 (2011)2026

Most influential descendants

Showing 5 of 12 · See all
  • K101825Cryoballoon Ablation SystemC2 Therapeutics · 2010 · cites it directly11descendants
  • K131523Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · 2 generations on10descendants
  • K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2015 · 3 generations on8descendants
  • K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc. · 2016 · 3 generations on6descendants
  • K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021387Polar WandChek-Med Systems2002—
+1K101825Cryoballoon Ablation SystemC2 Therapeutics2010—
+2K131523Cryoballoon Focal Ablation SystemC2 Therapeutics20132
+3K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon…C2 Therapeutics, Inc.2015—
+3K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe…C2 Therapeutics, Inc.20161
+4K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201510
201630
201710
201810
201910
202010
202110
202410
FIG. 1 — Lineage of K021387, 2002–2024Source: FDA 510(k) summaries, read by 510(k) Report · 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 510(k) statement (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. #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (12)

See all 12

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101825Cryoballoon Ablation SystemC2 Therapeutics201011

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, K101825 (C2 Therapeutics, 2010) has gone furthest, with 11 descendants of its own.

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 Polar Wand Cryotherapy System is used for ablation of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and gastroenterology. The system may be used with a variety of cryogens, e.g. carbon dioxide, nitrous oxide, argon, krypton.

Indications for use as stated in the FDA 510(k) statement.

More from Chek-Med Systems

3 FDA decisions under this applicant name. See the company

  • K041783Polar WandChek-Med Systems · 2004
  • K993951Spot Endoscopic MarkerChek-Med Systems · 2000

Recent decisions in GEH

The GEH category page

  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026
  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K021387 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021387: Polar Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021387

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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