510(k) · Cleared
Recalled · Class II · 20195 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument
Cleared on Jan 21, 2010 as substantially equivalent to K042855 (Intuitive Surgical, Inc., 2004) and 1 other predicate after a 100-day review. Its family tree reaches back 6 generations to 1994. 16 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 21, 2010
- Review
- 100 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 6 generations to K930667 (1994). 22 ancestors in all, the oldest K914190 (1992). 16 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 5 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 4 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 3 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 2 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 1 generation backK042855 Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004
- This deviceK093217 5 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 &…Intuitive Surgical, Inc. · 2010
- Descendant · cites it directly · 15 of its ownK112584 5MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace…Intuitive Surgical, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 9 of its ownK143132 IS4000 8mm Harmonic ACE Curved ShearsIntuitive Surgical, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK170865 EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci…Intuitive Surgical, Inc. · 2017
- Descendant · 4 generations on · 7 of its ownK173337 Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · Recalled
- Descendant · 5 generations on · 6 of its ownK183107 Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K1125845MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable…Intuitive Surgical, Inc. · 2011 · cites it directly15descendants
- K143132IS4000 8mm Harmonic ACE Curved ShearsIntuitive Surgical, Inc. · 2015 · 2 generations on9descendants
- K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc. · 2017 · 3 generations on8descendants
- K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · 4 generations on7descendants
- K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc. · 2018 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −5 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −4 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −3 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −2 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −1 | K042855 | Intuitive Surgical Harmonic Curved Shears Instrument | Intuitive Surgical, Inc. | 2004 | — |
| 0 (this device) | K093217 | 5 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System) | Intuitive Surgical, Inc. | 2010 | — |
| +1 | K112584 | 5MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert… | Intuitive Surgical, Inc. | 2011 | 1 |
| +2 | K143132 | IS4000 8mm Harmonic ACE Curved Shears | Intuitive Surgical, Inc. | 2015 | — |
| +3 | K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site… | Intuitive Surgical, Inc. | 2017 | — |
| +4 | K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018 | 1 |
| +5 | K183107 | Intuitive Surgical Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 NAY? 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 NAY device
- #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 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 |
|---|---|---|---|
| * | K042855 | Intuitive Surgical Harmonic Curved Shears InstrumentSummary page 2…fety or efficacy as compared to Intuitive Surgical's currently cleared Harmonic~m Curved Shears (K042855). Summary: Based on the technical characteristics. intended use and per… | 2004 |
| * | K042777 | Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PSummary page 1…K(042855, HarmoniCTM Curved Shears Instrument Ethicon Endo-Surgery, Inc. K042777. Harmonic ACErm with Hand Control Device Description: The Intuitive Surgical Harmonic ACEiMnDevice is… | 2004 |
What descends from it? (16)
See all 162 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2019 | Class II | Z-0841-2019 | Under Investigation by firm | During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few… |
| Jan 21, 2015 | Class II | Z-1118-2015 | Error in labeling | Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips. |
| Jan 21, 2015 | Class II | Z-1117-2015 | Error in labeling | Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K112584 (Intuitive Surgical, Inc., 2011) has gone furthest, with 15 descendants of its own.
- 5 other devices also cite its predicate K042855.
How does its category compare?
All NAY devicesNAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NAY
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NAY
117in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NAY
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NAY
48,456in 2025
MAUDE reports naming product code NAY, 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 | 0 | — | 11 | 133 |
| 2008 | 4 | 189 | 3 | 224 |
| 2009 | 3 | 253 | 1 | 380 |
| 2010 | 1 | — | 0 | 623 |
| 2011 | 7 | 191 | 2 | 501 |
| 2012 | 4 | 106 | 1 | 1,552 |
| 2013 | 4 | 144 | 6 | 6,217 |
| 2014 | 9 | 143 | 25 | 6,135 |
| 2015 | 3 | 99 | 3 | 1,722 |
| 2016 | 8 | 197 | 1 | 1,077 |
| 2017 | 16 | 107 | 1 | 1,049 |
| 2018 | 15 | 152 | 2 | 1,074 |
| 2019 | 8 | 73 | 5 | 1,154 |
| 2020 | 9 | 212 | 0 | 1,558 |
| 2021 | 11 | 61 | 3 | 1,997 |
| 2022 | 6 | 57 | 3 | 5,727 |
| 2023 | 5 | 141 | 2 (1) | 10,898 |
| 2024 | 10 | 126 | 40 | 12,872 |
| 2025 | 16 | 117 | 1 | 48,456 |
| 2026 | 7 | 89 | 4 (1) | — |
What is it indicated for?
The Intuitive Surgical da Vinci Harmonic ACE Device is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Model IS1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GENO4) and Hand Piece (Model HP054).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093217 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093217: 5 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093217
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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