510(k) · Cleared
ClearedUltracision Harmonic Scalpel Hand Piece
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 Mar 12, 1999 as substantially equivalent to K952726 (Ultracision, Inc., 1995) after a 29-day review. Its family tree reaches back 1 generation to 1995. 93 later devices descend from it.
- Decided
- Mar 12, 1999
- Review
- 29 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952726 (1995). 93 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- This deviceK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- Descendant · cites it directly · 49 of its ownK993868 The Soundvaser Dissection SystemSound Surgical Technologies, LLC · 1999 · Recalled
- Descendant · 2 generations on · 48 of its ownK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- Descendant · 3 generations on · 36 of its ownK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- Descendant · 4 generations on · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- Descendant · cites it directly · 19 of its ownK021962 Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K993868The Soundvaser Dissection SystemSound Surgical Technologies, LLC · 1999 · cites it directly49descendants
- K022051Soundvaser SystemSound Surgical Technologies, LLC · 2002 · 2 generations on48descendants
- K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004 · 3 generations on36descendants
- K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · 4 generations on34descendants
- K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003 · cites it directly19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| 0 (this device) | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| +1 | K993868 | The Soundvaser Dissection System | Sound Surgical Technologies, LLC | 1999 | 2 |
| +2 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| +3 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| +4 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| +1 | K021962 | Olympus Ultrasonic Surgical System | The Olympus Optical Co. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 9 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 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 |
|---|---|---|---|
| * | K952726 | Ultracision Harmonic ScapelSummary page 1…is the hand- held component of the Ultracision Instru- mentation. The instrument is for cutting and coagulating soft tissues. Ultracision Hand Piece with air cooling (K952726) The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal… | 1995 |
What descends from it? (93)
See all 937 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993868 | The Soundvaser Dissection System | 1999 | 49 |
| K021962 | Olympus Ultrasonic Surgical System | 2003 | 19 |
| K012464 | Helix Hydro-Jet | 2001 | 19 |
| K031523 | Olympus Ultrasonic Surgical System | 2003 | 18 |
| K031710 | Olympus Ultrasonic Surgical System | 2003 | 18 |
| K111202 | Surgical Tissue Management System | 2012 | 11 |
| K150271 | Prime Adaptive Ultrasonic Scalpel System | 2015 | 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?
- Its one ancestor has no recall.
- Of its descendants, K993868 (Sound Surgical Technologies, LLC, 1999) has gone furthest, with 49 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 Ultracision 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.
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/K990430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990430: Ultracision Harmonic Scalpel Hand Piece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990430
Report an extraction error
Are you the manufacturer?
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