510(k) · Cleared
Recalled · 2006Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices 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 Jan 13, 2006 as substantially equivalent to K021010 (Endocare, Inc., 2002) and 6 other predicates after a 35-day review. Its family tree reaches back 7 generations to 1995. 22 later devices descend from it. It has been recalled once.
- Decided
- Jan 13, 2006
- Review
- 35 days
- Class
- Class II
- Product code
- OCL
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 7 generations to K942299 (1995). 43 ancestors in all, the oldest K811390 (1981). 22 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 6 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 5 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 4 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 3 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 2 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 1 generation backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- This deviceK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006
- Descendant · cites it directly · 16 of its ownK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 14 of its ownK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- Descendant · 3 generations on · 13 of its ownK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- Descendant · 4 generations on · 11 of its ownK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- Descendant · 3 generations on · 10 of its ownK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · cites it directly16descendants
- K111042Atricure Cryo ModuleAtriCure, Inc. · 2011 · 2 generations on14descendants
- K112072Atricure Cryo Module SystemAtriCure, Inc. · 2011 · 3 generations on13descendants
- K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012 · 4 generations on11descendants
- K140058Atricure Cryo Module SystemAtriCure, Inc. · 2014 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −6 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −5 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −4 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −3 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −2 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −1 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| 0 (this device) | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | — |
| +1 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| +2 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
| +3 | K112072 | Atricure Cryo Module System | AtriCure, Inc. | 2011 | — |
| +4 | K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice) | AtriCure, Inc. | 2012 | — |
| +3 | K140058 | Atricure Cryo Module System | AtriCure, Inc. | 2014 | 2 |
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 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (7)
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…e: Cryosurgical Unit and Accessories Device Classification: Class II 3. PREDICATE DEVICES CryoCath Technologies - SurgiFrost® Cryosurgical System (K021010 & K040690) Endocare Inc. - CryoCare Cardiac Surgical System (K011040) CryoMedical Sciences - AccuProbe 45… | 2002 |
| * | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleSummary page 1…it and Accessories Device Classification: Class II 3. PREDICATE DEVICES CryoCath Technologies - SurgiFrost® Cryosurgical System (K021010 & K040690) Endocare Inc. - CryoCare Cardiac Surgical System (K011040) CryoMedical Sciences - AccuProbe 450, Accuprobe 550/5… | 2004 |
| * | K011040 | Cryocare Cardiac Surgical SystemSummary page 1…PREDICATE DEVICES CryoCath Technologies - SurgiFrost® Cryosurgical System (K021010 & K040690) Endocare Inc. - CryoCare Cardiac Surgical System (K011040) CryoMedical Sciences - AccuProbe 450, Accuprobe 550/530, Accuprobe 600 series (K973190) Boston Scientifi… | 2001 |
| * | K973190 | Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 SeriesSummary page 1…040690) Endocare Inc. - CryoCare Cardiac Surgical System (K011040) CryoMedical Sciences - AccuProbe 450, Accuprobe 550/530, Accuprobe 600 series (K973190) Boston Scientific - Cobra Bipolar System (K023288) Atricure Inc. - Atricure Bipolar Coagulation System (K020919)… | 1997 |
| * | K023288 | Cobra Bipolar Clamp, Model 15902Summary page 1…ystem (K011040) CryoMedical Sciences - AccuProbe 450, Accuprobe 550/530, Accuprobe 600 series (K973190) Boston Scientific - Cobra Bipolar System (K023288) Atricure Inc. - Atricure Bipolar Coagulation System (K020919) Medtronic Inc. - Cardioblate TM Radiofrequency Abl… | 2003 |
| * | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1Summary page 1…e 550/530, Accuprobe 600 series (K973190) Boston Scientific - Cobra Bipolar System (K023288) Atricure Inc. - Atricure Bipolar Coagulation System (K020919) Medtronic Inc. - Cardioblate TM Radiofrequency Ablation System (K013392) CryoCath Technologies Inc.,… | 2002 |
| * | K013392 | Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Summary page 1…ra Bipolar System (K023288) Atricure Inc. - Atricure Bipolar Coagulation System (K020919) Medtronic Inc. - Cardioblate TM Radiofrequency Ablation System (K013392) CryoCath Technologies Inc., Special 510(k) CoNFIDENlIAL SurgiFrost ®Surgical Cryoablation Syst… | 2002 |
What descends from it? (22)
See all 224 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082074 | Atricure CRYO1 Cryo-Ablation Probe | 2009 | 16 |
| K121878 | Cardioblate Cryoflex Surgical Ablation Probes | 2012 | 2 |
| 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2006 | Not classified | Z-0079-2007 | Other | Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiratation date while the correct date is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 43 ancestors have a recall of any class.
- Of its descendants, K082074 (AtriCure, Inc., 2009) has gone furthest, with 16 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® 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 6cm, 7cm and 10cm Cryosurgical Devices plus FrostByte™ 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/K053436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053436: Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053436
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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