510(k) · Cleared
ClearedUltracison Harmonic Scalpel HS2 Blade
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultracision, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 1, 1994 after a 74-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 36 later devices descend from it.
- Decided
- Jul 1, 1994
- Review
- 74 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 3 citing it directly.
- This deviceK941897 Ultracison Harmonic Scalpel HS2 BladeUltracision, Inc. · 1994
- Descendant · cites it directly · 33 of its ownK990362 Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc. · 1999
- Descendant · 2 generations on · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- Descendant · 2 generations on · 18 of its ownK031710 Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003
- Descendant · 3 generations on · 15 of its ownK050885 Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation · 2005
- Descendant · 3 generations on · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K990362Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc. · 1999 · cites it directly33descendants
- K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · 2 generations on18descendants
- K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003 · 2 generations on18descendants
- K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation · 2005 · 3 generations on15descendants
- K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941897 | Ultracison Harmonic Scalpel HS2 Blade | Ultracision, Inc. | 1994 | — |
| +1 | K990362 | Instrument, Ultrasonic, Scalpel | Ethicon Endo-Surgery, Inc. | 1999 | — |
| +2 | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| +2 | K031710 | Olympus Ultrasonic Surgical System | Aomori Olympus Co., Ltd. | 2003 | — |
| +3 | K050885 | Olympus Ultrasonic Surgical System Sonosurg | Olympus Medical Systems Corporation | 2005 | — |
| +3 | K111202 | Surgical Tissue Management System | Olympus Medical Systems Corp. | 2012 | 10 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (36)
See all 363 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, K990362 (Ethicon Endo-Surgery, Inc., 1999) has gone furthest, with 33 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
https://510kreport.com/device/K941897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941897: Ultracison Harmonic Scalpel HS2 Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941897
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026