510(k) · Cleared
ClearedMalleable Surgical Lightstic 180, Model 180 (1CM-9CM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiofocus, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 20, 2001 as substantially equivalent to K011988 (Cardiofocus, Inc., 2001) after a 24-day review. Its family tree reaches back 2 generations to 1998. 30 later devices descend from it.
- Decided
- Dec 20, 2001
- Review
- 24 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980668 (1998). 3 ancestors in all. 30 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK980668 CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790Cryomedical Sciences, Inc. · 1998
- 1 generation backK011988 Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001
- This deviceK013901 Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001
- Descendant · cites it directly · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- Descendant · cites it directly · 22 of its ownK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- Descendant · 2 generations on · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
- Descendant · 3 generations on · 10 of its ownK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008
- Descendant · 3 generations on · 6 of its ownK101174 Atricure Bipolar System Including Isolator Synergy Dual Electrode…AtriCure, Inc. · 2010
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · cites it directly23descendants
- K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc. · 2004 · cites it directly22descendants
- K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · 2 generations on18descendants
- K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc. · 2008 · 3 generations on10descendants
- K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc. · 2010 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980668 | CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790 | Cryomedical Sciences, Inc. | 1998 | — |
| −1 | K011988 | Surgical Lightstic 180, Model 180 L, Model 180 C | Cardiofocus, Inc. | 2001 | — |
| 0 (this device) | K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) | Cardiofocus, Inc. | 2001 | — |
| +1 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| +1 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| +2 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
| +3 | K080509 | Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation… | Medtronic, Inc. | 2008 | — |
| +3 | K101174 | Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model… | AtriCure, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K011988 | Surgical Lightstic 180, Model 180 L, Model 180 CSummary page 1…gical Laser Instrument Accessories Predicate Devices The Malleable Surgical Lightstic 180 for use in cardiac tissue is identical to the current Surgical Lightstic 180 (K011988), and substantially equivalent for indications for use in cardiac tissue. 24 Intended Use The Malleable Surgic… | 2001 |
What descends from it? (30)
See all 304 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K022894 (Epicor Medical, Inc., 2004) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K011988.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
Coagulation of Cardiac Tissue
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/K013901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013901: Malleable Surgical Lightstic 180, Model 180 (1CM-9CM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013901
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026