510(k) · Cleared
ClearedSurgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryocath Technologies, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on Apr 29, 2004 as substantially equivalent to K021010 (Endocare, Inc., 2002) and 5 other predicates after a 44-day review. Its family tree reaches back 6 generations to 1995. 42 later devices descend from it.
- Decided
- Apr 29, 2004
- Review
- 44 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K942299 (1995). 42 ancestors in all, the oldest K811390 (1981). 42 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 5 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 4 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 3 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 2 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 1 generation backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- This deviceK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- Descendant · cites it directly · 22 of its ownK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- Descendant · cites it directly · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- Descendant · 2 generations on · 16 of its ownK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 14 of its ownK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- Descendant · 4 generations on · 13 of its ownK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc. · 2006 · cites it directly22descendants
- K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · cites it directly18descendants
- K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · 2 generations on16descendants
- K111042Atricure Cryo ModuleAtriCure, Inc. · 2011 · 3 generations on14descendants
- K112072Atricure Cryo Module SystemAtriCure, Inc. · 2011 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −5 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −4 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −3 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −2 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −1 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| 0 (this device) | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| +1 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| +1 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
| +2 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| +3 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
| +4 | K112072 | Atricure Cryo Module System | AtriCure, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 OCL? 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 OCL device
- #1 K252056 Isolator® Synergy™ EnCompass Clamp and Guide…score 13.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K021010 | Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSESummary page 1…osurgical Unit and Accessories Device Classification: Class II 3. PREDICATE DEVICES CryoCath Technologies - SurgiFrosto Cryosurgical System (K02101 0) Endocare Inc. - CryoCare Cardiac Surgical System (KOI 1040) CryoMedical Sciences - AccuProbe 450, Accuprobe… | 2002 |
| * | K011040 | Cryocare Cardiac Surgical System | 2001 |
| * | K973190 | Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 SeriesSummary page 1…Endocare Inc. - CryoCare Cardiac Surgical System (KOI 1040) CryoMedical Sciences - AccuProbe 450, Accuprobe 550/530, Accuprobe 600 series (K973190) Boston Scientific - Cobra Bipolar System (K023288) Atricure Inc. - Atricure Bipolar Coagulation System (KO20… | 1997 |
| * | K023288 | Cobra Bipolar Clamp, Model 15902Summary page 1…KOI 1040) CryoMedical Sciences - AccuProbe 450, Accuprobe 550/530, Accuprobe 600 series (K973190) Boston Scientific - Cobra Bipolar System (K023288) Atricure Inc. - Atricure Bipolar Coagulation System (KO20919) Medtronic Inc. - Cardioblate TM Radiofrequency… | 2003 |
| * | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | 2002 |
| * | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation… | 2002 |
What descends from it? (42)
See all 424 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical… | 2006 | 22 |
| K043579 | Atricure Bipolar System | 2007 | 18 |
| K062140 | Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1 | 2006 | 1 |
| K070947 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist… | 2008 | 0 |
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 9 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 42 ancestors have a recall of any class.
- Of its descendants, K053436 (Cryocath Technologies, Inc., 2006) has gone furthest, with 22 descendants of its own.
- 2 other devices also cite its predicate K021010.
How does its category compare?
All OCL devicesOCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCL
85in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCL
46in 2025
MAUDE reports naming product code OCL, 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 | 3 | 139 | 0 | 0 |
| 2008 | 5 | 81 | 1 | 0 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 2 | — | 2 | 23 |
| 2011 | 2 | — | 0 | 21 |
| 2012 | 6 | 75 | 0 | 21 |
| 2013 | 2 | — | 1 | 13 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 31 |
| 2016 | 0 | — | 1 | 76 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 2 | — | 0 | 61 |
| 2019 | 6 | 85 | 4 | 49 |
| 2020 | 1 | — | 4 | 37 |
| 2021 | 2 | — | 1 | 63 |
| 2022 | 2 | — | 0 | 59 |
| 2023 | 0 | — | 0 | 99 |
| 2024 | 1 | — | 0 | 59 |
| 2025 | 1 | — | 0 | 46 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SurgiFrost® 10 cm Cryosurgical Device plus FrostByteTM Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByteTM Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.
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/K040690 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040690
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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