# Medtronic Xomed, Inc.

- Location (FDA's records): Jacksonville, FL
- FDA decisions: 48 (1983–2026): 47 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Medtronic Xomed, Inc. (39); Medtronic Xomed (9)
- Product codes: ETN (10), ERL (8), LRK (2), LYA (2), LRC (2), GWF (2), ETD (2), HBE (2), DXC (1), PNZ (1), EQJ (1), HRX (1)
- 510(k) review time since 2016: median 106 days, against 98 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 81 (22 its own); citations of its devices by later devices: 96 (22 its own)
- Recalls linked to its devices: 21 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Xomed, Inc.: 9 (https://510kreport.com/company/xomed)
- Sodemsystems: 8 (https://510kreport.com/company/sodemsystems)
- Treace Medical, Inc.: 6 (https://510kreport.com/company/treace-medical)
- Nicolet Biomedical Instruments: 3 (https://510kreport.com/company/nicolet-biomedical-instruments)
- Xomed-Treace, Inc.: 3 (https://510kreport.com/company/xomed-treace)
- Linvatec Corp.: 2 (https://510kreport.com/company/linvatec)
- Entellus Medical, Inc.: 2 (https://510kreport.com/company/entellus-medical)
- Nicolet Instrument Corp.: 2 (https://510kreport.com/company/nicolet-instrument)

## Firms that cite its devices most
- Medtronic Sofamor Danek USA, Inc.: 7 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Zethon, Ltd.: 3 (https://510kreport.com/company/zethon)
- Medtronic Surgical Technologies: 3 (https://510kreport.com/company/medtronic-surgical-technologies)
- Medtronic Powered Surgical Solutions: 3 (https://510kreport.com/company/medtronic-powered-surgical-solutions)
- Laurimed, LLC: 2 (https://510kreport.com/company/laurimed)
- Bien-Air Surgery SA: 2 (https://510kreport.com/company/bien-air-surgery)
- Cadwell Lab, Inc.: 2 (https://510kreport.com/company/cadwell-lab)
- Carbylan Biosurgery: 2 (https://510kreport.com/company/carbylan-biosurgery)

## Its most-cited devices
- K111520: Ipc Powerease System (2011), cited by 12
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] (2008), cited by 11
- K031003: Stimulus/Dissection Instruments, Ball-Tip Probes (2003), cited by 9
- K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent (2004), cited by 8
- K041523: XPS 3000 System (2004), cited by 7
- K083124: NIM 3.0 (2009), cited by 6

## Recent decisions
- K262235: ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM) (Sep 4, 2026)
- K251672: NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) (Feb 10, 2026)
- K230320: NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube (Oct 26, 2023)
- K231580: NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (Aug 30, 2023)
- K213246: NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long (Mar 21, 2022)
- K210841: NuVent Eustachian Tube Dilation Balloon (Aug 16, 2021)
- K202623: Novapak Nasal Sinus Packing and Stent (Dec 8, 2020)
- K200759: NIM Vital, Nerve Integrity Monitor (Oct 28, 2020)

Source page: https://510kreport.com/company/medtronic-xomed