510(k) · Cleared
ClearedHarmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with Ergonomic Handle
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 Oct 24, 2013 as substantially equivalent to K051036 (Ethicon Endo-Surgery, Inc., 2005) and 1 other predicate after a 73-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Oct 24, 2013
- Review
- 73 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K925699 (1993). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK925699 Harmonic Scalpel Laparosonic Clamp Coagulator Acc.Ultracision, Inc. · 1993
- 4 generations backK980099 Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc. · 1998
- 3 generations backK993054 Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5…Ethicon Endo-Surgery, Inc. · 1999
- 2 generations backK042777 Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc. · 2004
- 1 generation backK051036 Harmonic Ace Curved Shears with Pistol Handle and Hand Control…Ethicon Endo-Surgery, Inc. · 2005
- This deviceK132512 Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved…Ethicon Endo-Surgery, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925699 | Harmonic Scalpel Laparosonic Clamp Coagulator Acc. | Ultracision, Inc. | 1993 | — |
| −4 | K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −3 | K993054 | Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1… | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −2 | K042777 | Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36P | Ethicon Endo-Surgery, Inc. | 2004 | — |
| −1 | K051036 | Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P… | Ethicon Endo-Surgery, Inc. | 2005 | — |
| 0 (this device) | K132512 | Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears… | Ethicon Endo-Surgery, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K051036 | Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36PSummary page 2…redicate The Predicate devices are: Device o Harmonic ACE curved Shears with Scissor Handle and Hand Information Control cleared under K05 1036 & K060245 o Harmonic ACE Curved Shears with Pistol Handle and Hand Control cleared… | 2005 |
| * | K060245 | Harmonic Scalpel Blades and ShearsSummary page 2…The Predicate devices are: Device o Harmonic ACE curved Shears with Scissor Handle and Hand Information Control cleared under K05 1036 & K060245 o Harmonic ACE Curved Shears with Pistol Handle and Hand Control cleared under K05… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K051036.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Shears 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, 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.
https://510kreport.com/device/K132512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132512: Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with Ergonomic Handle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132512
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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