510(k) · Cleared
ClearedUltrasonic Surgical Aspirator System, Model FS 1000 RF
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 Oct 26, 2006 as substantially equivalent to K050776 (Misonix, Inc., 2005) and 2 other predicates after a 63-day review. Its family tree reaches back 3 generations to 1988. 6 later devices descend from it.
- Decided
- Oct 26, 2006
- Review
- 63 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K884413 (1988). 10 ancestors in all, the oldest K801623 (1980). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 2 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 1 generation backK051947 Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005
- This deviceK062471 Ultrasonic Surgical Aspirator System, Model FS 1000 RFMisonix, Inc. · 2006
- 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 · cites it directly · 1 of its ownK181367 Tenex Health TX System with the TXP MicroTipTenex Health, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK241700 Tenex 2nd Generation SystemTrice Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK212060 neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K202299Ultrasonic Surgical Aspirator SystemSmtp Technology Co., Ltd. · 2021 · cites it directly1descendant
- K190160neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2019 · cites it directly1descendant
- K181367Tenex Health TX System with the TXP MicroTipTenex Health, Inc. · 2018 · cites it directly1descendant
- K241700Tenex 2nd Generation SystemTrice Medical, Inc. · 2024 · 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 |
|---|---|---|---|---|---|
| −3 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −2 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −1 | K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone | Radionics, A Division of Tyco Healthcare Group LP | 2005 | — |
| 0 (this device) | K062471 | Ultrasonic Surgical Aspirator System, Model FS 1000 RF | Misonix, Inc. | 2006 | — |
| +1 | K202299 | Ultrasonic Surgical Aspirator System | Smtp Technology Co., Ltd. | 2021 | — |
| +1 | K190160 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2019 | — |
| +1 | K181367 | Tenex Health TX System with the TXP MicroTip | Tenex Health, Inc. | 2018 | — |
| +2 | K241700 | Tenex 2nd Generation System | Trice Medical, Inc. | 2024 | — |
| +2 | K212060 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2024 | 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? (4)
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…trasonic Surgical 3. Predicate Device Information Misonix Inc. AUSS-6 Ultrasonic Surgical Aspirator, 1(050776 Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator, 1(012028… | 2005 |
| * | K012028 | Alliger Ultrasonic Surgical System Model Auss-5Summary page 1…rgical Aspirator, 1(050776 Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator, 1(012028 Radionics CUSA EXCEL Ultrasonic Surgical Aspirator System with Bone T… | 2001 |
| * | K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneSummary page 1…1(012028 Radionics CUSA EXCEL Ultrasonic Surgical Aspirator System with Bone Tip, K05 1947 4. Device Description: The FS 1000 RF Ultrasonic Surgical Aspirator System is… | 2005 |
| * | — | Cusa NS-100 Named without a submission number |
What descends from it? (6)
3 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 18 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K202299 (Smtp Technology Co., Ltd., 2021) has gone furthest, with 1 descendant 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.
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 Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:
Neurosurgery
Gastrointestinal and Affiliated Organ Surgery
Urological Surgery
Plastic and Reconstructive Surgery
General Surgery
Orthopedic Surgery
Gynecological Surgery
Thoracic Surgery
Laparoscopic Surgery
Thoracoscopic Surgery
The system may also be combined with electrosurgery using optional RF Surgery interface components.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062471: Ultrasonic Surgical Aspirator System, Model FS 1000 RF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062471
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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