510(k) Report

FDA applicant

Xomed, Inc.

Jacksonville, FL82 decisions1976–20005 recalls

FDA records 82 decisions for Xomed, Inc. (Jacksonville, FL) from 1976 to 2000: 82 510(k) clearances. Most are in product codes ETD (Tube, Tympanostomy) and LXB (Hearing Aid, Bone Conduction). Its devices cite 32 predicates, 3 of them its own earlier devices. 5 recalls are linked to its devices.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Xomed, Inc. since 2007.

Recalls per year

2in 2016

2009: 12013: 12016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Xomed, 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?

  • ETDTube, Tympanostomy13decisions
  • LXBHearing Aid, Bone Conduction6decisions
  • KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)5decisions
  • ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece5decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • ETBProsthesis, Partial Ossicular Replacement3decisions

Also: KAM (3), EOB (2), EPP (2), ETN (2), QPB (2), JOF (2).

Whose devices does it build on?

Its devices cite 32 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 59 times; 3 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.

  • K992869Xomed Ball-Tip Monopolar Stimulator ProbeXomed, Inc. · 19997cite it
  • K982731Merogel Nasal Dressing and Sinus StentXomed, Inc. · 19997cite it
  • K001148Merogel Otologic PackXomed, Inc. · 20004cite it
  • K993655Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 19994cite it
  • K982594Endo-Scrub/Endo-Scrub 2Xomed, Inc. · 19983cite it
  • K861971Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 19863cite it

What has FDA decided for it lately?

  • K002395Model 30 Classic PneumatonometerXomed, Inc. · 2000
  • K002987Redtronic Xomed Monopolar Energized BladeXomed, Inc. · 2000
  • K002828XPS Nitro SystemXomed, Inc. · 20001 recall
  • K002897Titanium Middle Ear ProsthesesXomed, Inc. · 20001 recall
  • K993653Micro-France Trocars and AccessoriesXomed, Inc. · 2000
  • K001148Merogel Otologic PackXomed, Inc. · 2000
  • K994262Frontal Sinus Trephination CannulaXomed, Inc. · 2000
  • K992855XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptXomed, Inc. · 2000

All 82 as Xomed, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K993655Integra MicroFrance Monopolar and Bipolar Electrosurgical InstrumentsMar 7, 2016Class II
  • K993655Integra MicroFrance Monopolar and Bipolar Electrosurgical InstrumentsMar 7, 2016Class II
  • K002897Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear…Aug 23, 2013Class II
  • K002828Medtronic Integrated Power Console System, IP X1 REF 1898001 or REF EC300 Medtronic…Jul 17, 2009
  • K982594The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as…Jan 29, 2004

Other applicant names beginning “Xomed”

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

Xomed-Treace, Inc. 12