510(k) · Cleared
ClearedAxya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axya Medical, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Sep 10, 2002 as substantially equivalent to K895252 (Ultracision, Inc., 1989) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Sep 10, 2002
- Review
- 90 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K801623 (1980). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 2 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 1 generation backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- This deviceK021929 Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical SystemAxya Medical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −2 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −1 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| 0 (this device) | K021929 | Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical System | Axya Medical, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 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? (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 |
|---|---|---|---|
| * | K895252 | Ultracision Ultrasonic ScalpelSummary page 1…Class II Predicate Devices Ultracision, Inc. (currently marketed by Ethicon, Inc.) Ultrasonic Scalpel [501(k) Number K8952521 Olympus Optical Co. SonoSurgTMSystem [51O(k) Number K9721141. Description The Scnic U!trason… | 1989 |
| * | K972114 | Olympus Sonosurg SystemSummary page 1…rently marketed by Ethicon, Inc.) Ultrasonic Scalpel [501(k) Number K8952521 Olympus Optical Co. SonoSurgTMSystem [51O(k) Number K9721141. Description The Scnic U!trasonic Surcjcal System consists of an Uitrasonic Generatc; !Cc. Unit, a reusable handp… | 1998 |
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 22 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 11 ancestors has a recall.
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 Axya Model 100 Sonic Scalpel™ Ultrasonic Surgical System is indicated for use in
endoscopic and open surgical procedures for the cutting and coagulation of soft tissue
structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021929: Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021929
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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