510(k) · Cleared
ClearedMisonix, Inc., Auss-7 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 May 11, 2007 as substantially equivalent to K050776 (Misonix, Inc., 2005) after a 99-day review. Its family tree reaches back 2 generations to 1980. 8 later devices descend from it.
- Decided
- May 11, 2007
- Review
- 99 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K801623 (1980). 3 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 1 generation backK050776 Auss-6 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2005
- This deviceK070313 Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK153743 Piezosurgery PlusMectron S.P.A. · 2016
- Descendant · cites it directly · 1 of its ownK202299 Ultrasonic Surgical Aspirator SystemSmtp Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK190160 neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK243280 Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350…W&H Dentalwerk Buermoos GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK212060 neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153743Piezosurgery PlusMectron S.P.A. · 2016 · cites it directly2descendants
- K202299Ultrasonic Surgical Aspirator SystemSmtp Technology Co., Ltd. · 2021 · cites it directly1descendant
- K190160neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2019 · cites it directly1descendant
- K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…W&H Dentalwerk Buermoos GmbH · 2025 · 2 generations on0descendants
- K212060neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −1 | K050776 | Auss-6 Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2005 | — |
| 0 (this device) | K070313 | Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2007 | — |
| +1 | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
| +1 | K202299 | Ultrasonic Surgical Aspirator System | Smtp Technology Co., Ltd. | 2021 | — |
| +1 | K190160 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2019 | — |
| +2 | K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed… | W&H Dentalwerk Buermoos GmbH | 2025 | — |
| +2 | K212060 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2021 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 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? (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 |
|---|---|---|---|
| * | K050776 | Auss-6 Ultrasonic Surgical Aspirator SystemSummary page 1…: Instrument, Ultrasonic Surgical 3. Predicate Device Information Original Device: Misonix Inc. Ultrasonic Surgical Aspirator AUSS-6, K050776 4. Device Description The Ailiger Ultrasonic Surgical System is comprised of a generator,… | 2005 |
What descends from it? (8)
4 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?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 24.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K153743 (Mectron S.P.A., 2016) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K050776.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 (e.g.: bone) tissue in the following surgical specialties: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Gynecology External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primary and metastatic tumors of all types and…
Read the full statement (176 words)
The Alliger Ultrasonic Surgical System is indicated for use in the fragmentation and aspiration of both soft 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
Gynecology
External genitalia
- condyloma
- 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.
Thoracic Surgery
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
Wound Care
The Misonix Inc. AUSS-7 Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, bum wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070313 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070313: Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070313
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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