Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MUD — Predicate Candidate Screening
74 FDA 510(k) clearances under this product code; the 50 most recent screened below.
124 daysmedian FDA review time
274 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254129 | Spectrum-2 | Neko Health AB | 2026-05-22 | 151 | 0 |
| K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | 2025-07-17 | 267 | 0 |
| K250519 | Lap.Ox™ Laparoscopic Tissue Oximeter | ViOptix, Inc. | 2025-06-26 | 125 | 0 |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024-10-16 | 226 | 0 |
| K241393 | ODI-Tech | Odi Medical AS | 2024-08-30 | 106 | 0 |
| K240601 | SnapshotNIR model KD205 | Kent Imaging, Inc. | 2024-04-02 | 29 | 0 |
| K232385 | OxiplexTS200 | Iss Medical, Inc. | 2024-03-01 | 205 | 0 |
| K233488 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2024-02-28 | 124 | 0 |
| K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023-11-17 | 256 | 0 |
| K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023-05-26 | 171 | 0 |
| K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2022-05-06 | 130 | 0 |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2022-05-03 | 28 | 0 |
| K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, I | Covidien, LLC | 2021-12-05 | 199 | 1 |
| K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021-02-10 | 75 | 0 |
| K201976 | SnapshotNIR | Kent Imaging | 2020-11-10 | 117 | 1 |
| K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020-08-29 | 89 | 0 |
| K190334 | MIMOSA Imager | Mimosa Diagnostics, Inc. | 2019-11-01 | 260 | 0 |
| K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019-10-21 | 255 | 0 |
| K192322 | T-Stat 2.0 Microvascular Tissue Oximeter | Spectros Corporation | 2019-09-23 | 27 | 0 |
| K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2019-09-16 | 84 | 0 |
| K182429 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2019-06-07 | 274 | 0 |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, Sen | Nonin Medical, Inc. | 2019-05-02 | 58 | 0 |
| K182868 | INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor | Covidien, LLC | 2019-01-08 | 88 | 1 |
| K171245 | Presygen/si-1 | Christie Medical Holdings, Inc. | 2018-08-09 | 468 | 0 |
| K181623 | Clarifi Imaging System | Modulated Imaging, Inc. | 2018-07-19 | 29 | 0 |
| K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | 2018-05-10 | 128 | 0 |
| K163472 | Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. | 2017-11-16 | 339 | 0 |
| K162603 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2017-05-26 | 249 | 0 |
| K163070 | Kent Camera | Kent Imaging, Inc. | 2017-05-05 | 184 | 0 |
| K153426 | Ox-Imager CS | Modulated Imaging, Inc. | 2016-12-21 | 392 | 0 |
| K161237 | HyperView Hyperspectral Tissue Oxygenation Measurement Syste | Hypermed Imaging, Inc. | 2016-12-16 | 228 | 0 |
| K162117 | NIRO-200NX DP | Hamamatsu Photonics K.K. | 2016-10-25 | 88 | 0 |
| K160526 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2016-06-09 | 105 | 0 |
| K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediat | Nonin Medical, Inc. | 2015-08-27 | 101 | 0 |
| K143219 | NIRO-200NX | Hamamatsu Photonics K.K. | 2015-07-31 | 263 | 0 |
| K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2015-04-10 | 107 | 0 |
| K133983 | INTRA. OX HANDHELD TISSUE OXIMETER | Vioptix, Inc. | 2014-09-12 | 259 | 0 |
| K141496 | MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER | Reflectance Medical, Inc. | 2014-08-04 | 59 | 0 |
| K141234 | ODISSEY TISSUE OXIMETER | Vioptix, Inc. | 2014-07-01 | 49 | 0 |
| K133879 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | Cas Medical Systems, Inc. | 2014-04-29 | 130 | 0 |
| K133923 | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET | Reflectance Medical, Inc. | 2014-04-11 | 109 | 0 |
| K130079 | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER | Reflectance Medical, Inc. | 2013-07-19 | 186 | 0 |
| K123700 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | Cas Medical Systems, Inc. | 2013-04-11 | 129 | 0 |
| K122645 | MOBILE CAREGUIDE 2100 OXIMETER | Reflectance Medical, Inc. | 2012-12-05 | 97 | 0 |
| K112826 | NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR | Moor Instruments, Ltd. | 2012-10-10 | 378 | 0 |
| K113507 | KENT CAMERA | Kent Imaging, Inc. | 2012-08-08 | 254 | 0 |
| K113656 | CAREGUIDE OXIMETER | Reflectance Medical, Inc. | 2012-07-26 | 227 | 0 |
| K113215 | MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY | Nonin Medical, Inc. | 2012-05-14 | 195 | 0 |
| K112820 | FORE-SIGHT ABSOLUTE TISSUE OXIMETER | Cas Medical Systems, Inc. | 2012-01-26 | 120 | 0 |
| K103613 | INPECTRA STO2 SPOT CHECK | Hutchinson Technology, Inc. | 2011-03-02 | 83 | 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