510(k) · Cleared
ClearedHarmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36P
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 Jun 2, 2005 as substantially equivalent to K042777 (Ethicon Endo-Surgery, Inc., 2004) after a 38-day review. Its family tree reaches back 4 generations to 1993. 14 later devices descend from it.
- Decided
- Jun 2, 2005
- Review
- 38 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K925699 (1993). 6 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK925699 Harmonic Scalpel Laparosonic Clamp Coagulator Acc.Ultracision, Inc. · 1993
- 3 generations backK980099 Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc. · 1998
- 2 generations backK993054 Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5…Ethicon Endo-Surgery, Inc. · 1999
- 1 generation backK042777 Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc. · 2004
- This deviceK051036 Harmonic Ace Curved Shears with Pistol Handle and Hand Control…Ethicon Endo-Surgery, Inc. · 2005
- Descendant · cites it directly · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
- Descendant · 2 generations on · 9 of its ownK132703 ThunderbeatOlympus Medical Systems Corp. · 2014
- Descendant · 3 generations on · 6 of its ownK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- Descendant · 4 generations on · 4 of its ownK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- Descendant · 3 generations on · 4 of its ownK172610 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5…Olympus Medical Systems Corp. · 2018 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · cites it directly11descendants
- K132703ThunderbeatOlympus Medical Systems Corp. · 2014 · 2 generations on9descendants
- K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016 · 3 generations on6descendants
- K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020 · 4 generations on4descendants
- K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp. · 2018 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925699 | Harmonic Scalpel Laparosonic Clamp Coagulator Acc. | Ultracision, Inc. | 1993 | — |
| −3 | K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −2 | K993054 | Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1… | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −1 | K042777 | Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36P | Ethicon Endo-Surgery, Inc. | 2004 | — |
| 0 (this device) | K051036 | Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P… | Ethicon Endo-Surgery, Inc. | 2005 | — |
| +1 | K111202 | Surgical Tissue Management System | Olympus Medical Systems Corp. | 2012 | 10 |
| +2 | K132703 | Thunderbeat | Olympus Medical Systems Corp. | 2014 | — |
| +3 | K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016 | — |
| +4 | K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020 | — |
| +3 | K172610 | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm… | Olympus Medical Systems Corp. | 2018 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K042777 | Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PSummary page 1…ith Scissor Handle and Hand Control Classification Name: Electrosurgical Cutting and Coagulation Device Predicate Devices: Harmonic ACE with Hand Control cleared under K042777 on 12/01/2004 Device Description The Harmonic ACE TM Curved Shears with Pistol Handle and Hand Control and Harmonic ACE TM Curve… | 2004 |
What descends from it? (14)
See all 143 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)
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 12 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K111202 (Olympus Medical Systems Corp., 2012) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K042777.
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 ACE™ Curved Shears with Pistol Handle and Hand Control is 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, pediatric, gynecologic, urologic and other open and endoscopic procedures. The Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control is indicated for soft tissue…
Read the full statement (108 words)
The Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control is 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, pediatric, gynecologic, urologic and other open and endoscopic
procedures.
The Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control is 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, pediatric, gynecologic, urologic and other open and endoscopic
procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051036 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051036: Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051036
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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