510(k) · Cleared
ClearedAtrilaze Malleable Ablation Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Cv, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 11, 2005 as substantially equivalent to K040744 (Medical Cv, Inc., 2004) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1998. 4 later devices descend from it.
- Decided
- Oct 11, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K980668 (1998). 7 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK980668 CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790Cryomedical Sciences, Inc. · 1998
- 2 generations backK011988 Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001
- 1 generation backK013901 Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001
- This deviceK052495 Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK060680 Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK081457 Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK061489 Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK082409 Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000…Endophotonix, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K060680Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006 · cites it directly3descendants
- K081457Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008 · 2 generations on1descendant
- K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007 · cites it directly1descendant
- K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000…Endophotonix, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980668 | CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790 | Cryomedical Sciences, Inc. | 1998 | — |
| −2 | K011988 | Surgical Lightstic 180, Model 180 L, Model 180 C | Cardiofocus, Inc. | 2001 | — |
| −1 | K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) | Cardiofocus, Inc. | 2001 | — |
| 0 (this device) | K052495 | Atrilaze Malleable Ablation Probe | Medical Cv, Inc. | 2005 | — |
| +1 | K060680 | Atrilaze Surgical Ablation System | Medical Cv, Inc. | 2006 | — |
| +2 | K081457 | Atrilaze Laser Ablation System | Medical Cv, Inc. | 2008 | — |
| +1 | K061489 | Atrilaze MI Surgical Ablation System | Medical Cv, Inc. | 2007 | — |
| +2 | K082409 | Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083… | Endophotonix, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K040744 | Atrilaze Soft Tissue Ablation SystemSummary page 2…ogical Comparison: The Atrilaze Malleable S-2 Disposable Probe is the same as that of the existing Non-Malleable Disposible Probe that was granted market clearance under K040744. The fiber optic delivery system (probe) is coupled to the laser via an SMA 905 connector to deliver laser radiation to the targe… | 2004 |
| * | K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) | 2001 |
What descends from it? (4)
2 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 7 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K060680 (Medical Cv, Inc., 2006) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K040744.
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?
The MedicalCV, Inc. Atrilaze Surgical Ablation System is indicated for delivery of 810nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue.
Warning: The Atrilaze Surgical Ablation System is not indicated for the treatment of cardiac arrhythmias.
The risk of actual damage to adjacent organs from the instrument exists and perforation, rupture or tearing of tissue, may occur as a complication of laser use. Burns can occur if the laser energy is not correctly applied. These complications may be serious
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/K052495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052495: Atrilaze Malleable Ablation Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052495
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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