Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medtronic Xomed, Inc. · Predicate Candidate Screening
37 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
256 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251672 | NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ | Medtronic Xomed, Inc. | 2026-02-10 | 256 | 0 |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinf | Medtronic Xomed, Inc. | 2023-10-26 | 262 | 0 |
| K231580 | NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35 | Medtronic Xomed, Inc. | 2023-08-30 | 91 | 0 |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Pr | Medtronic Xomed, Inc. | 2022-03-21 | 172 | 0 |
| K210841 | NuVent Eustachian Tube Dilation Balloon | Medtronic Xomed, Inc. | 2021-08-16 | 147 | 0 |
| K200759 | NIM Vital, Nerve Integrity Monitor | Medtronic Xomed, Inc. | 2020-10-28 | 218 | 4 |
| K173855 | Sharpsite AC Rigid Endsocope | Medtronic Xomed, Inc. | 2018-04-20 | 121 | 0 |
| K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | 2015-12-01 | 124 | 0 |
| K151758 | ALAR Nasal Valve Stent | Medtronic Xomed, Inc. | 2015-10-29 | 122 | 0 |
| K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | Medtronic Xomed, Inc. | 2015-08-14 | 147 | 0 |
| K151067 | Ventilation (Tympanostomy) Tubes | Medtronic Xomed, Inc. | 2015-07-22 | 92 | 0 |
| K132297 | EM SINUS DILATION SYSTEM | Medtronic Xomed, Inc. | 2013-11-05 | 104 | 0 |
| K122391 | MEDTRONIC XOMED, INC. | Medtronic Xomed, Inc. | 2013-01-10 | 156 | 0 |
| K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE | Medtronic Xomed, Inc. | 2012-06-27 | 286 | 2 |
| K110623 | PILLAR PALATAL IMPLANT SYSTEM | Medtronic Xomed, Inc. | 2012-02-10 | 344 | 0 |
| K112662 | MICROFRANCE(R) WORMALD VASCULAR CLAMP | Medtronic Xomed, Inc. | 2012-01-20 | 129 | 0 |
| K111520 | IPC POWEREASE SYSTEM | Medtronic Xomed, Inc. | 2011-10-26 | 146 | 2 |
| K083124 | NIM 3.0 | Medtronic Xomed, Inc. | 2009-02-27 | 128 | 3 |
| K081475 | ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS | Medtronic Xomed, Inc. | 2008-10-17 | 143 | 2 |
| K081277 | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POW | Medtronic Xomed, Inc. | 2008-09-05 | 123 | 0 |
| K080257 | MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS | Medtronic Xomed, Inc. | 2008-05-22 | 112 | 0 |
| K073255 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2008-03-24 | 126 | 0 |
| K063305 | STIMULATING BUR GUARD | Medtronic Xomed, Inc. | 2006-11-29 | 28 | 0 |
| K053430 | TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER | Medtronic Xomed, Inc. | 2006-03-03 | 84 | 0 |
| K050162 | CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE | Medtronic Xomed, Inc. | 2005-03-03 | 37 | 1 |
| K041381 | MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT | Medtronic Xomed, Inc. | 2004-09-10 | 108 | 0 |
| K041985 | XPS CURVED BUR | Medtronic Xomed, Inc. | 2004-08-12 | 20 | 0 |
| K041523 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2004-07-23 | 45 | 0 |
| K041413 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2004-07-12 | 46 | 0 |
| K031003 | STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES | Medtronic Xomed, Inc. | 2003-04-11 | 11 | 1 |
| K024316 | NIM-PRS | Medtronic Xomed, Inc. | 2003-01-06 | 11 | 0 |
| K022370 | FRAMELOCK; FRAMELOCK ACCESSORIES | Medtronic Xomed, Inc. | 2002-10-18 | 88 | 0 |
| K014165 | STIMULUS - DISSECTION INSTRUMENTS | Medtronic Xomed, Inc. | 2002-01-22 | 34 | 0 |
| K011191 | MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHT | Medtronic Xomed, Inc. | 2001-06-26 | 68 | 0 |
| K011321 | MODIFICATION TO XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2001-06-26 | 60 | 0 |
| K010666 | XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNU | Medtronic Xomed, Inc. | 2001-05-07 | 62 | 0 |
| K010677 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2001-05-07 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda