510(k) · Cleared
ClearedHarmonic Scalpel Blades and Shears
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Apr 7, 2006 after a 66-day review. The FDA summary names its predicate without a number. 52 later devices descend from it.
- Decided
- Apr 7, 2006
- Review
- 66 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 10 citing it directly.
- This deviceK060245 Harmonic Scalpel Blades and ShearsEthicon Endo-Surgery, Inc. · 2006
- Descendant · cites it directly · 22 of its ownK120729 Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive…Ethicon Endo-Surgery, LLC · 2012
- Descendant · cites it directly · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- Descendant · 2 generations on · 16 of its ownK132612 Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic…Ethicon Endo-Surgery, LLC · 2013 · Recalled
- Descendant · 2 generations on · 9 of its ownK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- Descendant · 3 generations on · 6 of its ownK160752 HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36…Ethicon Endo-Suregery, LLC · 2016
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K120729Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology…Ethicon Endo-Surgery, LLC · 2012 · cites it directly22descendants
- K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · cites it directly18descendants
- K132612Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…Ethicon Endo-Surgery, LLC · 2013 · 2 generations on16descendants
- K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013 · 2 generations on9descendants
- K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthEthicon Endo-Suregery, LLC · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060245 | Harmonic Scalpel Blades and Shears | Ethicon Endo-Surgery, Inc. | 2006 | — |
| +1 | K120729 | Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue… | Ethicon Endo-Surgery, LLC | 2012 | — |
| +1 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| +2 | K132612 | Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace +… | Ethicon Endo-Surgery, LLC | 2013 | 1 |
| +2 | K133314 | Harmonic Focus Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2013 | — |
| +3 | K160752 | HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length | Ethicon Endo-Suregery, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 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 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 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 |
|---|---|---|---|
| * | — | Harmonic Scalpel Blades and Shears Named without a submission number |
What descends from it? (52)
See all 5210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120729 | Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology… | 2012 | 22 |
| K100597 | Harmonic Focus Shears | 2010 | 18 |
| K101797 | Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB… | 2011 | 5 |
| K121550 | Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue Technology | 2012 | 2 |
| K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery System | 2007 | 2 |
| K151136 | Harmonic Hook | 2016 | 1 |
| K132566 | Reprocessed Harmonic Shear | 2014 | 0 |
| K133672 | Reprocessed Harmonic Ace Shears Without Adaptive Tissue Technology | 2014 | 0 |
| K132522 | Harmonic Ace Curved Shears with Ergonomic Handle | 2013 | 0 |
| K132512 | Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with… | 2013 | 0 |
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?
- Of its descendants, K120729 (Ethicon Endo-Surgery, LLC, 2012) has gone furthest, with 22 descendants of its own.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, 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 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
The Harmonic Shears 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. The Harmonic Scalpel 5mm Instruments with Protective Sleeve is…
Read the full statement (385 words)
The Harmonic Shears 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.
The Harmonic Scalpel 5mm Instruments with Protective Sleeve is 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, gynecologic, exposure to orthopedic structures (such as spine and joint space), ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 10cm Sharp Curved Blade Instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic Scalpel 10cm Curved Blade Instrument is intended to cut and coagulate soft tissue. It is to be used when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space, ENT (Ears, Nose, Throat) and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 5 mm Instruments 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, exposure to orthopedic structures (such as spine and joint space), plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic Scalpel 10 mm LaparoSonic Instruments 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, gynecologic, and exposure to orthopedic structures (such as spine and joint space).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060245: Harmonic Scalpel Blades and Shears.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060245
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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