510(k) · Cleared
ClearedUltracision Harmonic Scalpel Blades with Protective Sleeve, Models DH105, DH145, SH105, SH145
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 Oct 1, 2001 after an 81-day review. The FDA summary names its predicate without a number. 27 later devices descend from it.
- Decided
- Oct 1, 2001
- Review
- 81 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 2 citing it directly.
- This deviceK012176 Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models…Ethicon Endo-Surgery, Inc. · 2001
- Descendant · cites it directly · 26 of its ownK031305 Olympus Ultrasonic Surgical SystemOlympus Optical Co., Ltd. · 2003
- Descendant · cites it directly · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- Descendant · 2 generations on · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
- Descendant · 3 generations on · 9 of its ownK132703 ThunderbeatOlympus Medical Systems Corp. · 2014
- Descendant · 2 generations on · 9 of its ownK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K031305Olympus Ultrasonic Surgical SystemOlympus Optical Co., Ltd. · 2003 · cites it directly26descendants
- K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · cites it directly18descendants
- K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · 2 generations on11descendants
- K132703ThunderbeatOlympus Medical Systems Corp. · 2014 · 3 generations on9descendants
- K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012176 | Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models DH105… | Ethicon Endo-Surgery, Inc. | 2001 | — |
| +1 | K031305 | Olympus Ultrasonic Surgical System | Olympus Optical Co., Ltd. | 2003 | — |
| +1 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| +2 | K111202 | Surgical Tissue Management System | Olympus Medical Systems Corp. | 2012 | 10 |
| +3 | K132703 | Thunderbeat | Olympus Medical Systems Corp. | 2014 | — |
| +2 | K133314 | Harmonic Focus Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | — | UltraCision® Harmonic Scalpel® Blades with Protective Sleeve Named without a submission number |
What descends from it? (27)
See all 272 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?
- Of its descendants, K031305 (Olympus Optical Co., Ltd., 2003) has gone furthest, with 26 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 Scalpel 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 scalpel in general, gynecologic, ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of Internal Mammary Artery (IMA).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012176: Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models DH105, DH145, SH105, SH145.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012176
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026