510(k) · Cleared
ClearedSenhance Ultrasonic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asensus Surgical · NAY System, Surgical, Computer Controlled Instrument
Cleared on May 12, 2026 as substantially equivalent to K120729 (Ethicon Endo-Surgery, LLC, 2012) after a 140-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- May 12, 2026
- Review
- 140 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060245 (2006). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060245 | Harmonic Scalpel Blades and Shears | Ethicon Endo-Surgery, Inc. | 2006 | — |
| −1 | K120729 | Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue… | Ethicon Endo-Surgery, LLC | 2012 | — |
| 0 (this device) | K254192 | Senhance Ultrasonic System | Asensus Surgical | 2026 | — |
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? (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 |
|---|---|---|---|
| * | K120729 | Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology…Summary page 5…Predicate Device Information Primary Predicate Device: HARMONIC ACE® Shears + Adaptive Tissue Technology (K120729) Reference Device: Senhance Ultrasonic System (K182421) Device Description: The Senhance Ultrasonic… | 2012 |
| † | K182421 | Senhance Ultrasonic System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K120729.
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. 2026, 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 Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The instruments are indicated for the sealing of vessels up to and including 5 mm in diameter. The Senhance Ultrasonic System and accessories are indicated for use with the Senhance Surgical System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254192: Senhance Ultrasonic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254192
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026