510(k) · Cleared
ClearedHeartport Maze System: Cryoprobe Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartport, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Cleared on May 9, 1997 after an 88-day review. The FDA summary names its predicate without a number. 1 of the 394 devices in its family, counting itself, has a Class I recall. 393 later devices descend from it.
- Decided
- May 9, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- OCL
- Recalls
- None
- Predicates
- 0
393 later devices descend from it, 6 citing it directly. 1 of the 394 devices in this family, counting this one, has a Class I recall.
- This deviceK970496 Heartport Maze System: Cryoprobe SetHeartport, Inc. · 1997
- Descendant · cites it directly · 392 of its ownK974320 Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
- Descendant · cites it directly · 340 of its ownK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
- Descendant · cites it directly · 268 of its ownK041340 Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004
- Descendant · 2 generations on · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- Descendant · 3 generations on · 231 of its ownK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
Showing 5 of 393 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223095 Senhance Surgical System5 generations on · 2023
Most influential descendants
Showing 5 of 393 · See all- K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998 · cites it directly392descendants
- K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002 · cites it directly340descendants
- K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004 · cites it directly268descendants
- K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · 2 generations on251descendants
- K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc. · 2005 · 3 generations on231descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970496 | Heartport Maze System: Cryoprobe Set | Heartport, Inc. | 1997 | — |
| +1 | K974320 | Cryogen Cardiac Cryosurgical System | Cryogen, Inc. | 1998 | — |
| +1 | K013946 | Flex 10 Accessory for the Afx Microwave Ablation System | Afx, Inc. | 2002 | — |
| +1 | K041340 | Guidant Microwave Ablation System | Guidant Corporation, Cardiac Surgery | 2004 | — |
| +2 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| +3 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 14 | 0 |
| 2007 | 6 | 0 |
| 2008 | 15 | 0 |
| 2009 | 8 | 0 |
| 2010 | 4 | 0 |
| 2011 | 9 | 0 |
| 2012 | 13 | 0 |
| 2013 | 9 | 0 |
| 2014 | 17 | 0 |
| 2015 | 7 | 0 |
| 2016 | 14 | 0 |
| 2017 | 18 | 0 |
| 2018 | 25 | 0 |
| 2019 | 20 | 0 |
| 2020 | 27 | 0 |
| 2021 | 22 | 0 |
| 2022 | 22 | 0 |
| 2023 | 27 | 1 |
| 2024 | 35 | 0 |
| 2025 | 35 | 0 |
| 2026 | 29 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | — | Frigitronics® CCS-200 Cardiac Cryosurgical System Named without a submission number | |
| * | — | Spembly Medical - Cardiac Cryounit and associated Cardiac Cryoprobes Named without a submission number |
What descends from it? (393)
See all 3936 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974320 | Cryogen Cardiac Cryosurgical System | 1998 | 392 |
| K013946 | Flex 10 Accessory for the Afx Microwave Ablation System | 2002 | 340 |
| K041340 | Guidant Microwave Ablation System | 2004 | 268 |
| K011722 | Atricure Bipolar Coagulation System | 2001 | 92 |
| K082074 | Atricure CRYO1 Cryo-Ablation Probe | 2009 | 16 |
| K152337 | cryoFORM cryoICE cryoablation probe | 2016 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K974320 (Cryogen, Inc., 1998) has gone furthest, with 392 descendants of its own.
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 Heartport™ Maze System: Cryoprobe Set is intended for use in minimally invasive cardiac surgery procedures, including the surgical treatment of cardiac arrhythmias. The cryoprobes are applied to tissue and frozen to cause a block of electrical conduction through tissue by way of an inflammatory response, or cryonecrosis. The Set includes probes of varied tip shapes to optimize access to the treatment site.
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/K970496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970496: Heartport Maze System: Cryoprobe Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970496
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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