510(k) · Cleared
ClearedAuss-6 Ultrasonic Surgical Aspirator System
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 Jun 6, 2005 as substantially equivalent to K801623 (Cavitron Corp., 1980) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1980. 17 later devices descend from it.
- Decided
- Jun 6, 2005
- Review
- 70 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K801623 (1980). 2 ancestors in all. 17 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- This deviceK050776 Auss-6 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2005
- Descendant · cites it directly · 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 · cites it directly · 5 of its ownK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · Recalled
- Descendant · 2 generations on · 2 of its ownK153743 Piezosurgery PlusMectron S.P.A. · 2016
- Descendant · cites it directly · 2 of its ownK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K070313Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2007 · cites it directly8descendants
- K062471Ultrasonic Surgical Aspirator System, Model FS 1000 RFMisonix, Inc. · 2006 · cites it directly6descendants
- K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · cites it directly5descendants
- K153743Piezosurgery PlusMectron S.P.A. · 2016 · 2 generations on2descendants
- K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| 0 (this device) | K050776 | Auss-6 Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2005 | — |
| +1 | 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 | — |
| +1 | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | 1 |
| +2 | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
| +1 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K801623 | Cavitron Ultrasonic Surg. Aspir. CusaSummary page 1…Surgical 3. Predicate Device Information Predicate Devices CUSA NS-100 Ultrasonic Surgical Aspirator System K801623 Alliger Ultrasonic Surgical System AUSS-5 K012028 4.… | 1980 |
| * | K012028 | Alliger Ultrasonic Surgical System Model Auss-5Summary page 1…ator System K801623 Alliger Ultrasonic Surgical System AUSS-5 K012028 4. Device Description The AUSS-6 Ultrasonic Surgical System is comprised of a… | 2001 |
What descends from it? (17)
See all 176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070313 | Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System | 2007 | 8 |
| K062471 | Ultrasonic Surgical Aspirator System, Model FS 1000 RF | 2006 | 6 |
| K062544 | AR1000 Ultrasonic Wound Therapy System | 2007 | 5 |
| K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | 2011 | 2 |
| K181367 | Tenex Health TX System with the TXP MicroTip | 2018 | 1 |
| K072904 | Sonoca 180/195 Wound Care System | 2008 | 1 |
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?
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 AUSS-6 Ultrasonic Surgical System and Accessories are indicated for use in the fragmentation and aspiration of both solt and hard (e.g.: bone) tissue in the following surgical specialties: Neurosurgery; Gastrointestinal and Affiliated Organ Surgery; Urological Surgery; Plastic and Reconstructive Surgery; General Surgery; Orthopedic Surgery; Gynecology; External genitalia — condylorna, benign tumors (lipomas, fibromas, and leiomyomas)…
Read the full statement (175 words)
The Alliger AUSS-6 Ultrasonic Surgical System and Accessories are indicated for use in the fragmentation and aspiration of both solt and hard (e.g.: bone) tissue in the following surgical specialties: Neurosurgery; Gastrointestinal and Affiliated Organ Surgery; Urological Surgery; Plastic and Reconstructive Surgery; General Surgery; Orthopedic Surgery; Gynecology; External genitalia — condylorna, benign tumors (lipomas, fibromas, and leiomyomas), malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts.
Abdominal area any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus.
1Thoracic Surgery Limited pulmonary reception such as segmetectomies, nonanatomnical subsegmentectomies and metastatectomies.
Wound Care The Misonix Inc. AUSS-6 Utrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050776: Auss-6 Ultrasonic Surgical Aspirator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050776
Report an extraction error
Are you the manufacturer?
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