510(k) Report

510(k) · Decided

Decided

Cryosurgical Unit and Accessories

K003050510(k) TraditionalDecided Dec 26, 200085-day reviewClass II21 CFR 878.4400

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

Cryogen, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 26, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 93 later devices descend from it.

Decided
Dec 26, 2000
Review
85 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2004: 3 descendants cleared2008: 10 descendants cleared2002: 1 descendant cleared2006: 10 descendants cleared2011: 4 descendants cleared2003: 1 descendant cleared2005: 2 descendants cleared2007: 4 descendants cleared2010: 3 descendants cleared2012: 7 descendants cleared2009: 3 descendants cleared2021: 2 descendants cleared2022: 3 descendants cleared2019: 8 descendants cleared2018: 5 descendants cleared2014: 5 descendants cleared2013: 2 descendants cleared2025: 2 descendants cleared2024: 6 descendants cleared2020: 2 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2015: 1 descendant cleared2026: 4 descendants cleared2023: 2 descendants cleared200020052010201520202025
  1. This deviceK003050 Cryosurgical Unit and AccessoriesCryogen, Inc. · 2000
  2. Descendant · cites it directly · 92 of its ownK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  3. Descendant · 2 generations on · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
  4. Descendant · 3 generations on · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
  5. Descendant · 3 generations on · 34 of its ownK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
  6. Descendant · 2 generations on · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004

Showing 5 of 93 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 12004: 32005: 22006: 102007: 42008: 102009: 32010: 32011: 42012: 72013: 22014: 52015: 12016: 12017: 12018: 52019: 82020: 22021: 22022: 32023: 22024: 62025: 22026: 4
2001high 10 (2006) · low 1 (2001)2026

Most influential descendants

Showing 5 of 93 · See all
  • K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001 · cites it directly92descendants
  • K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · 2 generations on90descendants
  • K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · 3 generations on42descendants
  • K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003 · 3 generations on34descendants
  • K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · 2 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003050Cryosurgical Unit and AccessoriesCryogen, Inc.2000—
+1K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.2001—
+2K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.2002—
+3K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2004—
+3K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular2003—
+2K022894Epicor Medical Ablation SystemEpicor Medical, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200310
200430
200520
2006100
200740
2008100
200930
201030
201140
201270
201320
201450
201510
201610
201710
201850
201980
202020
202120
202230
202320
202460
202520
202640
FIG. 1 — Lineage of K003050, 2000–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (93)

See all 93

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

NumberDeviceApplicantDecidedDescendants
K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.200192

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, K011722 (AtriCure, Inc., 2001) has gone furthest, with 92 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

More from Cryogen, Inc.

4 FDA decisions under this applicant name. See the company

  • K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
  • K972662Cryogen Cryosurgical SystemCryogen, Inc. · 1997
  • K964971Cryogen Cryosurgical SystemCryogen, Inc. · 1997

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https://510kreport.com/device/K003050 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003050: Cryosurgical Unit and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003050

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026