510(k) · Cleared
Recalled · Class II · 2018Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC · LFL Instrument, Ultrasonic Surgical
Cleared on Aug 22, 2012 as substantially equivalent to K120729 (Ethicon Endo-Surgery, LLC, 2012) and 2 other predicates after an 89-day review. Its family tree reaches back 5 generations to 1980. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 22, 2012
- Review
- 89 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K801623 (1980). 28 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 4 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 3 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 2 generations backK021962 Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
- 1 generation backK050885 Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation · 2005
- This deviceK121550 Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive…Ethicon Endo-Surgery, LLC · 2012
- Descendant · cites it directly · 0 of its ownK161086 Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm)…Sterilmed, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK132566 Reprocessed Harmonic ShearSterilmed, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −4 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −3 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −2 | K021962 | Olympus Ultrasonic Surgical System | The Olympus Optical Co. | 2003 | — |
| −1 | K050885 | Olympus Ultrasonic Surgical System Sonosurg | Olympus Medical Systems Corporation | 2005 | — |
| 0 (this device) | K121550 | Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue… | Ethicon Endo-Surgery, LLC | 2012 | — |
| +1 | K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm)… | Sterilmed, Inc. | 2016 | — |
| +1 | K132566 | Reprocessed Harmonic Shear | Sterilmed, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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 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? (3)
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 |
|---|---|---|---|
| * | K120729 | Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology…Summary page 1…ame: Instrument, Ultrasonic Surgical Classification Name: Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL) Predicate Devices: K 120729: HARMONIC ACE® Shears + Adaptive Tissue Technology K050885: SonoSurg Short Curved Scissors 5 mm G.D., HF… | 2012 |
| * | K050885 | Olympus Ultrasonic Surgical System SonosurgSummary page 1…rument, Ultrasonic Surgical (Unassigned, Product Code LFL) Predicate Devices: K 120729: HARMONIC ACE® Shears + Adaptive Tissue Technology K050885: SonoSurg Short Curved Scissors 5 mm G.D., HF Series, Pistol and Inline Grip submitted as part… | 2005 |
| * | K060245 | Harmonic Scalpel Blades and ShearsSummary page 1…eries, Pistol and Inline Grip submitted as part of the Olympus Ultrasonic Surgical System SonoSurg K060245: HARMONIC Scalpel 5 mm Instruments by Ethicon Endo- Surgery Device Description: The… | 2006 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 3, 2018 | Class II | Z-2049-2018 | Other | The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device. |
| May 3, 2018 | Class II | Z-2048-2018 | Other | The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K161086 (Sterilmed, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K120729.
How does its category compare?
All LFL devicesLFL 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
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 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, thoracic, 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.
https://510kreport.com/device/K121550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121550: Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121550
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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