510(k) Report

510(k) · Cleared

Cleared

Atrilaze MI Surgical Ablation System

K061489510(k) AbbreviatedCleared Mar 16, 2007289-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Cv, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Mar 16, 2007 as substantially equivalent to K040744 (Medical Cv, Inc., 2004) and 4 other predicates after a 289-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.

Decided
Mar 16, 2007
Review
289 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K980668 (1998). 19 ancestors in all, the oldest K811390 (1981). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2002: 2 other ancestors2001: 1 other ancestor2000: 2 other ancestors1998: 1 other ancestor1997: 3 other ancestors1988: 1 other ancestor1981: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestor2009: 1 descendant clearedK980668 · CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790 · Cryomedical Sciences, Inc. · 1998×2: 2 generations cleared close together, K011988 (2001), K013901 (2001) K052495 · Atrilaze Malleable Ablation Probe · Medical Cv, Inc. · 2005K060680 · Atrilaze Surgical Ablation System · Medical Cv, Inc. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 3 other ancestors4 generations back: 4 other ancestors 1 generation forward: 1 descendant K060680 · Atrilaze Surgical Ablation System · Medical Cv, Inc. · 2006K052495 · Atrilaze Malleable Ablation Probe · Medical Cv, Inc. · 2005K013901 · Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) · Cardiofocus, Inc. · 2001K011988 · Surgical Lightstic 180, Model 180 L, Model 180 C · Cardiofocus, Inc. · 2001K980668 · CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790 · Cryomedical Sciences, Inc. · 1998−50
  1. Root · 5 generations backK980668 CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790Cryomedical Sciences, Inc. · 1998
  2. 4 generations backK011988 Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001
  3. 3 generations backK013901 Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001
  4. 2 generations backK052495 Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
  5. 1 generation backK060680 Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
  6. This deviceK061489 Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007
  7. Descendant · cites it directly · 0 of its ownK082409 Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000…Endophotonix, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000…Endophotonix, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K980668CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790Cryomedical Sciences, Inc.1998—
−4K011988Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc.2001—
−3K013901Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc.2001—
−2K052495Atrilaze Malleable Ablation ProbeMedical Cv, Inc.2005—
−1K060680Atrilaze Surgical Ablation SystemMedical Cv, Inc.2006—
0 (this device)K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc.2007—
+1K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083…Endophotonix, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199110
199510
199730
199810
200020
200110
200220
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K061489, 1998–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K040744Atrilaze Soft Tissue Ablation System
Summary page 2
…oses of this submission, the SolarTM Surgical Ablation System was compared to the following predicate devices: * Medical CV Atrilaze TM Surgical Ablation System (K040744,K052495 & K060680) * Guidant's Microwave FLEXIO Surgical Ablation System (K003978 & K013946) Testing: The results…
Medical Cv, Inc.2004—
*K052495Atrilaze Malleable Ablation Probe
Summary page 2
…this submission, the SolarTM Surgical Ablation System was compared to the following predicate devices: * Medical CV Atrilaze TM Surgical Ablation System (K040744,K052495 & K060680) * Guidant's Microwave FLEXIO Surgical Ablation System (K003978 & K013946) Testing: The results of bioc…
Medical Cv, Inc.2005—
*K060680Atrilaze Surgical Ablation System
Summary page 2
…ssion, the SolarTM Surgical Ablation System was compared to the following predicate devices: * Medical CV Atrilaze TM Surgical Ablation System (K040744,K052495 & K060680) * Guidant's Microwave FLEXIO Surgical Ablation System (K003978 & K013946) Testing: The results of biocompatibili…
Medical Cv, Inc.2006—
*K003978Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N…
Summary page 2
…ing predicate devices: * Medical CV Atrilaze TM Surgical Ablation System (K040744,K052495 & K060680) * Guidant's Microwave FLEXIO Surgical Ablation System (K003978 & K013946) Testing: The results of biocompatibility testing conducted on the disposable fiber optic delivery system an…
Afx, Inc.2001—
*K013946Flex 10 Accessory for the Afx Microwave Ablation System
Summary page 2
…ate devices: * Medical CV Atrilaze TM Surgical Ablation System (K040744,K052495 & K060680) * Guidant's Microwave FLEXIO Surgical Ablation System (K003978 & K013946) Testing: The results of biocompatibility testing conducted on the disposable fiber optic delivery system and tubing s…
Afx, Inc.2002—

Also cleared against K040744: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000…Endophotonix, Inc.20090

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 9 years and passes through 3 companies; a new generation was cleared every 11 months on median.
  • None of the 19 ancestors has a recall.
  • Of its descendants, K082409 (Endophotonix, Inc., 2009) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K040744.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

The MedicalCV SOLAR™ Surgical Ablation System is indicated for delivery of 810nm or 1064nm laser light to soft tissue, under direct visualization, during surgical procedures. Indications include the ablation, or coagulation of soft tissue.

Indications for use as stated in the FDA summary.

Also cleared against K040744

2 other devices cite the same predicate.

  • K060680Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
  • K052495Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005

More from Medical Cv, Inc.

14 FDA decisions under this applicant name. See the company

  • K081457Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008
  • K060680Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
  • K052495Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
  • K040744Atrilaze Soft Tissue Ablation SystemMedical Cv, Inc. · 2004
  • K033685Northrup Universal Annuloplasty System, Model 1000Medical Cv, Inc. · 2004

Recent decisions in GEX

The GEX category page

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https://510kreport.com/device/K061489 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061489: Atrilaze MI Surgical Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061489

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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