510(k) Report

FDA applicant

Misonix, Inc.

Farmingdale, NY18 decisions1998–20261 recall

FDA records 18 decisions for Misonix, Inc. (Farmingdale, NY) from 1998 to 2026: 18 510(k) clearances. Most are in product codes LFL (Instrument, Ultrasonic Surgical) and NRB (Wound Cleaner, Ultrasound). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 11 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Misonix, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Misonix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 12008: 12011: 12013: 12019: 12021: 12022: 12026 (partial year): 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Misonix, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Misonix, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LFLInstrument, Ultrasonic Surgical11decisions
  • NRBWound Cleaner, Ultrasound2decisions
  • NTBSystem, Ablation, Ultrasound And Accessories2decisions
  • QPBSystem, Suction, Lipoplasty For Removal1decision
  • GBXCatheter, Irrigation1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 105 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 101 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 32 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K050776Auss-6 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 20056cite it
  • K070313Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 20074cite it
  • K062471Ultrasonic Surgical Aspirator System, Model FS 1000 RFMisonix, Inc. · 20063cite it
  • K041058Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc. · 20042cite it
  • K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 20112cite it
  • K012028Alliger Ultrasonic Surgical System Model Auss-5Misonix, Inc. · 20012cite it

What has FDA decided for it lately?

  • K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC · 2026
  • K221235neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022
  • K212060neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2021
  • K190160neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2019
  • K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013
  • K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
  • K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc. · 2008
  • K070313Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2007

All 17 as Misonix, Inc. →The one decision as Misonix, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K0410585mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number…Jul 27, 2007

Other applicant names beginning “Misonix”

FDA records each applicant name separately; these may or may not be the same firm.

Misonix, LLC, A Bioventus Company 1