510(k) · Cleared
ClearedAlliger Ultrasonic Surgical System Model Auss-5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Misonix, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Jul 27, 2001 after a 29-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Jul 27, 2001
- Review
- 29 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK012028 Alliger Ultrasonic Surgical System Model Auss-5Misonix, Inc. · 2001
- Descendant · cites it directly · 17 of its ownK050776 Auss-6 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2005
- Descendant · 2 generations on · 8 of its ownK070313 Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK062471 Ultrasonic Surgical Aspirator System, Model FS 1000 RFMisonix, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · Recalled
- Descendant · 3 generations on · 2 of its ownK153743 Piezosurgery PlusMectron S.P.A. · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K050776Auss-6 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2005 · cites it directly17descendants
- K070313Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2007 · 2 generations on8descendants
- K062471Ultrasonic Surgical Aspirator System, Model FS 1000 RFMisonix, Inc. · 2006 · cites it directly6descendants
- K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · 2 generations on5descendants
- K153743Piezosurgery PlusMectron S.P.A. · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012028 | Alliger Ultrasonic Surgical System Model Auss-5 | Misonix, Inc. | 2001 | — |
| +1 | K050776 | Auss-6 Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2005 | — |
| +2 | K070313 | Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2007 | — |
| +1 | K062471 | Ultrasonic Surgical Aspirator System, Model FS 1000 RF | Misonix, Inc. | 2006 | — |
| +2 | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | 1 |
| +3 | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | Alliger Ultrasonic Surgical System model AUSS-4 Named without a submission number | |
| * | — | Cavitron Ultrasonic Surgical Aspirator (CUSA) Model NS-100 Ultrasonic Surgical Aspirator Named without a submission number |
What descends from it? (18)
See all 182 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, K050776 (Misonix, Inc., 2005) has gone furthest, with 17 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 Alliger Ultrasonic Surgical System is indicated for use in the fragmentation and aspiration of both soft and hard (c.g.: bone) tissue in the fallowing surgical specialties: Neurosurgery Gastrointcstinal and Affiliated Organ Surgcry Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthepedic Surgery Gynecology External genitalia ¢ condyloma * benign tumors (lipomas, fibromas, and lciomyomas) » malignent primary and metastabc…
Read the full statement (119 words)
The Alliger Ultrasonic Surgical System is indicated for use in the fragmentation and aspiration of both soft and hard (c.g.: bone) tissue in the fallowing surgical specialties:
Neurosurgery
Gastrointcstinal and Affiliated Organ Surgcry
Urological Surgery
Plastic and Reconstructive Surgery
General Surgery
Orthepedic Surgery
Gynecology
External genitalia
¢ condyloma
* benign tumors (lipomas, fibromas, and lciomyomas)
» malignent primary and metastabc turnors of all types and the following cystc lesions:
» Bartholin’s cysts
» Vestibular adenitis
» Inclusion cysts
» Sebaceous cysts
Abdominal area
e Any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tubc, uterus, or the supporting structures of the uterus.
Thoracic Surgery
¢ Limited pulmonary resection such as segmetectomies, nonanatarmical subsegmentectomics, and metastatectomies
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/K012028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012028: Alliger Ultrasonic Surgical System Model Auss-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012028
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026