510(k) Report

FDA applicant

Medtronic Xomed, Inc.

Jacksonville, FL48 decisions1983–202621 recalls

FDA records 48 decisions for Medtronic Xomed, Inc. (Jacksonville, FL) from 1983 to 2026: 47 510(k) clearances and 1 original PMA approval. Most are in product codes ETN (Stimulator, Nerve) and ERL (Drill, Surgical, Ent (Electric Or Pneumatic)…). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 81 predicates, 22 of them its own earlier devices. 21 recalls are linked to its devices, 3 Class I.

FDA’s records also spell it “Medtronic Xomed”.

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 Medtronic Xomed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2008: 42009: 12011: 12012: 42013: 22015: 42018: 12020: 22021: 12022: 12023: 22026 (partial year): 2
2007high 4 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2025

2007: 12008: 12010: 32013: 1, 1 Class I2014: 12016: 12019: 32021: 32022: 3, 1 Class I2023: 12024: 1, 1 Class I2025: 2
2007high 3 (2010) · low 0 (2009)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • ETNStimulator, Nerve10decisions
  • ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece8decisions
  • LRKDevice, Anti-Snoring2decisions
  • LYASplint, Intranasal Septal2decisions
  • LRCInstrument, Ent Manual Surgical2decisions
  • GWFStimulator, Electrical, Evoked Response2decisions

Also: ETD (2), HBE (2), DXC (1), PNZ (1), EQJ (1), HRX (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 106 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 98 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 81 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 96 times; 22 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.

  • K111520Ipc Powerease SystemMedtronic Xomed, Inc. · 201112cite it
  • K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)]Medtronic Xomed, Inc. · 200811cite it
  • K031003Stimulus/Dissection Instruments, Ball-Tip ProbesMedtronic Xomed, Inc. · 20039cite it
  • K041381Meropack Bioresorbable Nasal Packing and Sinus StentMedtronic Xomed, Inc. · 20048cite it
  • K041523XPS 3000 SystemMedtronic Xomed, Inc. · 20047cite it
  • K083124NIM 3.0Medtronic Xomed, Inc. · 20096cite it

What has FDA decided for it lately?

  • K262235ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking…Medtronic Xomed, Inc. · 2026
  • K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™…Medtronic Xomed, Inc. · 2026
  • K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeMedtronic Xomed, Inc. · 2023
  • K231580NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)Medtronic Xomed, Inc. · 2023
  • K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe…Medtronic Xomed, Inc. · 2022
  • K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc. · 2021
  • K202623Novapak Nasal Sinus Packing and StentMedtronic Xomed · 2020
  • K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. · 20201 Class I recall

All 39 as Medtronic Xomed, Inc. →All 9 as Medtronic Xomed →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K111520IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC…Jul 17, 2025Class II
  • K200759NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE…Mar 10, 2025Class II
  • K200759NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital…Jun 24, 2024Class I
  • K112686NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM…Nov 7, 2023Class II
  • K200759NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2May 3, 2022Class II
  • K200759NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2May 3, 2022Class II