Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Navigation, Inc. — Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
255 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | 2026-03-26 | 177 | 0 |
| K253395 | Stealth AXiS™ ENT clinical application | Medtronic Navigation, Inc. | 2026-03-16 | 167 | 0 |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualas | Medtronic Navigation, Inc. | 2026-03-13 | 164 | 0 |
| K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clini | Medtronic Navigation, Inc. | 2026-02-12 | 135 | 0 |
| K251282 | StealthStation S8 Spine Software | Medtronic Navigation, Inc. | 2025-10-17 | 176 | 0 |
| K242464 | Stealth™ Spine Clamps; ModuLeX™ Shank Mounts | Medtronic Navigation, Inc. | 2025-06-05 | 290 | 0 |
| K240465 | O-arm O2 Imaging System | Medtronic Navigation, Inc. | 2024-06-21 | 126 | 2 |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | 2023-10-19 | 108 | 0 |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | Medtronic Navigation, Inc. | 2022-06-10 | 58 | 2 |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | 2022-01-07 | 255 | 1 |
| K203639 | StealthStation Cranial Software v1.3.2 | Medtronic Navigation, Inc. | 2021-01-13 | 30 | 0 |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Soft | Medtronic Navigation, Inc. | 2020-06-26 | 99 | 0 |
| K201175 | StealthStation Cranial Software v1.3.0 | Medtronic Navigation, Inc. | 2020-06-03 | 33 | 0 |
| K201189 | Stealthstation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc. | 2020-05-29 | 28 | 1 |
| K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | Medtronic Navigation, Inc. | 2019-11-01 | 137 | 0 |
| K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthS | Medtronic Navigation, Inc. | 2019-07-31 | 138 | 1 |
| K181859 | Visualase Thermal Therapy System | Medtronic Navigation, Inc. | 2019-03-06 | 237 | 1 |
| K170018 | StealthStationTM S8 ENT Software | Medtronic Navigation, Inc. | 2017-05-19 | 136 | 0 |
| K162655 | StealthConnect Remote Viewing, Planning and Collaboration Sy | Medtronic Navigation, Inc. | 2017-04-21 | 210 | 0 |
| K162309 | StealthStation S8 System Platforms and StealthStation Crania | Medtronic Navigation, Inc. | 2017-03-31 | 226 | 2 |
| K162604 | Cranial Reducing Tubes | Medtronic Navigation, Inc. | 2016-12-30 | 102 | 0 |
| K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016-09-14 | 268 | 3 |
| K153555 | EM ENT Navigated Suctions | Medtronic Navigation, Inc. | 2016-04-07 | 115 | 0 |
| K153247 | Fusion Compact Navigation System | Medtronic Navigation, Inc. | 2016-02-18 | 101 | 0 |
| K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015-06-11 | 132 | 2 |
| K141833 | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATI | Medtronic Navigation, Inc. | 2015-03-25 | 261 | 2 |
| K133444 | STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NA | Medtronic Navigation, Inc. | 2014-07-25 | 255 | 0 |
| K133665 | MALLEABLE SUCTION INSTRUMENTS | Medtronic Navigation, Inc. | 2014-03-13 | 104 | 0 |
| K131425 | NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLY | Medtronic Navigation, Inc. | 2013-08-14 | 89 | 3 |
| K130608 | QUADCUT | Medtronic Navigation, Inc. | 2013-08-07 | 153 | 1 |
| K124004 | NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, | Medtronic Navigation, Inc. | 2013-03-22 | 86 | 1 |
| K081512 | STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PAC | Medtronic Navigation, Inc. | 2008-07-18 | 49 | 0 |
| K061248 | AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM | Medtronic Navigation, Inc. | 2006-08-31 | 120 | 0 |
| K052623 | IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM | Medtronic Navigation, Inc. | 2006-03-02 | 160 | 0 |
| K050651 | MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION | Medtronic Navigation, Inc. | 2005-07-27 | 135 | 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