510(k) Report

510(k) · Cleared

Cleared

Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology Harmonic Ace 5MM Diameter Shears 23

K120729510(k) TraditionalCleared May 17, 201269-day reviewClass U

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

Ethicon Endo-Surgery, LLC · LFL Instrument, Ultrasonic Surgical

Cleared on May 17, 2012 as substantially equivalent to K060245 (Ethicon Endo-Surgery, Inc., 2006) after a 69-day review. Its family tree reaches back 1 generation to 2006. 22 later devices descend from it.

Decided
May 17, 2012
Review
69 days
Class
Class U
Product code
LFL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K060245 (2006). 22 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2016: 3 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2026: 2 descendants cleared2023: 1 descendant cleared2021: 2 descendants cleared2020: 3 descendants cleared2025: 3 descendants cleared2022: 1 descendant cleared2017: 1 descendant cleared2024: 3 descendants clearedK060245 · Harmonic Scalpel Blades and Shears · Ethicon Endo-Surgery, Inc. · 200620052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 4 descendants K060245 · Harmonic Scalpel Blades and Shears · Ethicon Endo-Surgery, Inc. · 20060+5
  1. Root · 1 generation backK060245 Harmonic Scalpel Blades and ShearsEthicon Endo-Surgery, Inc. · 2006
  2. This deviceK120729 Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive…Ethicon Endo-Surgery, LLC · 2012
  3. Descendant · cites it directly · 16 of its ownK132612 Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic…Ethicon Endo-Surgery, LLC · 2013 · Recalled
  4. Descendant · 2 generations on · 6 of its ownK160752 HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36…Ethicon Endo-Suregery, LLC · 2016
  5. Descendant · 3 generations on · 5 of its ownK191555 HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36…Ethicon Endo-Surgery, LLC · 2020 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length…Ethicon Endo-Surgery, LLC · 2020
  7. Descendant · cites it directly · 2 of its ownK121550 Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive…Ethicon Endo-Surgery, LLC · 2012 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 12016: 32017: 12020: 32021: 22022: 12023: 12024: 32025: 32026: 2
2012high 3 (2016) · low 0 (2015)2026

Most influential descendants

Showing 5 of 22 · See all
  • K132612Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…Ethicon Endo-Surgery, LLC · 2013 · cites it directly16descendants
  • K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthEthicon Endo-Suregery, LLC · 2016 · 2 generations on6descendants
  • K191555HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthEthicon Endo-Surgery, LLC · 2020 · 3 generations on5descendants
  • K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC · 2020 · 4 generations on4descendants
  • K121550Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2012 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K060245Harmonic Scalpel Blades and ShearsEthicon Endo-Surgery, Inc.2006—
0 (this device)K120729Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue…Ethicon Endo-Surgery, LLC2012—
+1K132612Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace +…Ethicon Endo-Surgery, LLC20131
+2K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthEthicon Endo-Suregery, LLC2016—
+3K191555HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthEthicon Endo-Surgery, LLC20202
+4K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC2020—
+1K121550Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue…Ethicon Endo-Surgery, LLC20122

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201410
201630
201710
202030
202120
202210
202310
202430
202530
202620
FIG. 1 — Lineage of K120729, 2006–2026Source: 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 LFL? 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 LFL device

  1. #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K060245Harmonic Scalpel Blades and Shears
Summary page 1
…ion Name Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL) Predicate Device Harmonic ACE® Curved Shears with Pistol Handle and Hand Control cleared under K060245 on April 7, 2006 Device Description: The Ethicon Endo-Surgery HARMONIC ACE®'Shears + Adaptive Tissue Technology are used for co…
Ethicon Endo-Surgery, Inc.2006—

Also cleared against K060245: 9 other devices →

What descends from it? (22)

See all 22

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132612Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…Ethicon Endo-Surgery, LLC201316
K121550Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20122
K254192Senhance Ultrasonic SystemAsensus Surgical20260
K151405Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings (Dba Medline Renewal20160
K132566Reprocessed Harmonic ShearSterilmed, Inc.20140

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?

  • Its one ancestor has no recall.
  • Of its descendants, K132612 (Ethicon Endo-Surgery, LLC, 2013) has gone furthest, with 16 descendants of its own.
  • 9 other devices also cite its predicate K060245.

How does its category compare?

All LFL devices

LFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LFL

3in 2025

2007: 72008: 22009: 12010: 22011: 32012: 32013: 52014: 32015: 42016: 52017: 22018: 32019: 42020: 42021: 62022: 82023: 42024: 32025: 32026 (partial year): 3
2007high 8 (2022) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFL

176in 2025

2007: 99 days median2011: 241 days median2012: 82 days median2013: 73 days median2014: 136 days median2015: 99 days median2016: 111 days median2018: 66 days median2019: 103 days median2020: 190 days median2021: 83 days median2022: 168 days median2023: 104 days median2024: 158 days median2025: 176 days median2026 (partial year): 99 days median
2007high 241 (2011) · low 66 (2018)2026

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

Recalls per year · LFL

11in 2024

2010: 32011: 22012: 52014: 12015: 12017: 12019: 422021: 12023: 22024: 112026 (partial year): 1
2007high 42 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFL

3,857in 2025

2007: 2,2362008: 1,6782009: 3,3242010: 1,2392011: 1,0532012: 1,4912013: 2,4302014: 4,2602015: 2,7772016: 2,6912017: 3,2672018: 3,4612019: 3,1532020: 2,9342021: 3,2892022: 3,4222023: 4,2152024: 4,0172025: 3,857
2007high 4,260 (2014) · low 1,053 (2011)2025

MAUDE reports naming product code LFL, 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
200779902,236
20082—01,678
20091—03,324
20102—31,239
2011324121,053
201238251,491
201357302,430
2014313614,260
201549912,777
2016511102,691
20172—13,267
201836603,461
20194103423,153
2020419002,934
202168313,289
2022816803,422
2023410424,215
20243158114,017
2025317603,857
20263991—

What is it indicated for?

The HARMONIC ACE® Shears + Adaptive Tissue Technology are indicated for soft tissue

incisions when bleeding control and minimal thermal injury are desired. The instruments can be

used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic,

pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space)

and other open and endoscopic procedures.

Indications for use as stated in the FDA summary.

Also cleared against K060245

9 other devices cite the same predicate.

  • K151136Harmonic HookEthicon Endo-Surgery, LLC · 2016
  • K132566Reprocessed Harmonic ShearSterilmed, Inc. · 2014
  • K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions · 2014
  • K132522Harmonic Ace Curved Shears with Ergonomic HandleEthicon Endo-Surgery, LLC · 2013
  • K132512Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with Ergonomic HandleEthicon Endo-Surgery, LLC · 2013
  • K121550Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 20122 recalls

More from Ethicon Endo-Surgery, LLC

70 FDA decisions under this applicant name. See the company

  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler…Ethicon Endo-Surgery, LLC · 2026
  • K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC · 2026
  • K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000…Ethicon Endo-Surgery, LLC · 2025
  • K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025

Recent decisions in LFL

The LFL category page

  • K261361TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque…Carl Zeiss Meditec, AG · 2026
  • K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+…Stryker Instruments · 2026
  • K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC · 2026
  • K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2025
  • K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced…Shanghai Saints Sages Surgical Co., Ltd. · 2025

https://510kreport.com/device/K120729 · printed Nov 5, 2026

Cite this page

510(k) Report. “K120729: Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology Harmonic Ace 5MM Diameter Shears 23.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120729

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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