510(k) · Cleared
ClearedAtricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 19, 2002 as substantially equivalent to K011722 (AtriCure, Inc., 2001) after a 29-day review. Its family tree reaches back 5 generations to 1995. 90 later devices descend from it.
- Decided
- Apr 19, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K942299 (1995). 31 ancestors in all, the oldest K811390 (1981). 90 later devices descend from it, 9 citing it directly.
- Root · 5 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 4 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 3 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 2 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 1 generation backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- This deviceK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- Descendant · cites it directly · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- Descendant · cites it directly · 34 of its ownK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- Descendant · cites it directly · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, 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 · 2 generations on · 22 of its ownK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
Showing 5 of 90 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 90 · See all- K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · cites it directly42descendants
- K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003 · cites it directly34descendants
- K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · cites it directly23descendants
- K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc. · 2006 · cites it directly22descendants
- K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc. · 2004 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −4 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −3 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −2 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −1 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| 0 (this device) | 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 | — |
| +1 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| +1 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| +1 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| +2 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 9 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011722 | Atricure Bipolar Coagulation SystemSummary page 1…eric/Common Name: Electrosurgical cutting and coagulation device and Accessories 21CFR 878.4400 Predicate Devices 1. AtriCure Inc. AtriCure Bipolar Coagulation System K011722 2. AtriCure Inc. AtriCure Bipolar Coagulation System K010122 Indication For Use Statement The AtriCure Bipolar Coagulation Syst… | 2001 |
| Kept off the family tree | K010122 | FDA’s K010122 is Continuous Flow Y-Tubing Our OCR of the scanned summary read K010122, FDA’s number for Continuous Flow Y-Tubing (G.U.-Tek). Its FDA name has none of the distinctive words the summary uses for the device it names, “AtriCure Bipolar Coagulation System”. Kept off the family tree. Summary page 1…ice and Accessories 21CFR 878.4400 Predicate Devices 1. AtriCure Inc. AtriCure Bipolar Coagulation System K011722 2. AtriCure Inc. AtriCure Bipolar Coagulation System K010122 Indication For Use Statement The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during Gen… | 2001 |
What descends from it? (90)
See all 909 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console | 2004 | 42 |
| K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | 2003 | 34 |
| K022894 | Epicor Medical Ablation System | 2004 | 23 |
| K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical… | 2006 | 22 |
| K043579 | Atricure Bipolar System | 2007 | 18 |
| K050459 | Atricure Isolator Transpolar Pen | 2005 | 18 |
| K052893 | Atricure Transpolar System | 2005 | 8 |
| K063630 | Atricure Ablation System | 2007 | 7 |
| K110117 | Atricure Bipolar System | 2011 | 5 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 31 ancestors has a recall of any class.
- Of its descendants, K040690 (Cryocath Technologies, Inc., 2004) has gone furthest, with 42 descendants of its own.
- 3 other devices also cite its predicate K011722.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The AtriCure Bipolar System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology and Urology surgical procedures.
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/K020919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020919
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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