Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Medical Systems Information Technologies, Inc. — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
131 daysmedian FDA review time
260 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; | Ge Medical Systems Information Technologies, Inc. | 2026-07-24 | 298 | 0 |
| K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2026-01-26 | 241 | 0 |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; | Ge Medical Systems Information Technologies, Inc. | 2025-07-09 | 315 | 0 |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (Alti | Ge Medical Systems Information Technologies, Inc. | 2024-12-12 | 27 | 0 |
| K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024-04-25 | 147 | 1 |
| K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait | Ge Medical Systems Information Technologies, Inc. | 2024-03-20 | 83 | 2 |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac | Ge Medical Systems Information Technologies, Inc. | 2023-12-13 | 170 | 1 |
| K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Port | Ge Medical Systems Information Technologies, Inc. | 2023-08-11 | 157 | 0 |
| K230145 | ONE-CUF | Ge Medical Systems Information Technologies, Inc. | 2023-03-14 | 55 | 1 |
| K222586 | Mural Clinical Viewer | Ge Medical Systems Information Technologies, Inc. | 2022-12-21 | 117 | 0 |
| K221904 | EK12 V2 Algorithm | Ge Medical Systems Information Technologies, Inc. | 2022-12-20 | 173 | 0 |
| K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2022-10-18 | 165 | 1 |
| K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | 2022-06-23 | 101 | 0 |
| K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 an | Ge Medical Systems Information Technologies, Inc. | 2022-04-12 | 194 | 1 |
| K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, | Ge Medical Systems Information Technologies, Inc. | 2022-04-01 | 151 | 6 |
| K203786 | MAC 7 - Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2021-04-30 | 123 | 0 |
| K202189 | Graffiti | Ge Medical Systems Information Technologies, Inc. | 2020-12-08 | 126 | 0 |
| K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020-11-04 | 114 | 0 |
| K173830 | MAC VU360 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2018-09-18 | 274 | 3 |
| K170155 | EK12 Algorithm | Ge Medical Systems Information Technologies, Inc. | 2017-06-06 | 139 | 0 |
| K152993 | MUSE Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2016-01-12 | 91 | 0 |
| K141963 | 12SL ECG ANALYSIS PROGRAM | Ge Medical Systems Information Technologies, Inc. | 2015-02-05 | 202 | 0 |
| K133882 | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) | Ge Medical Systems Information Technologies, Inc. | 2014-04-30 | 131 | 0 |
| K132437 | MARS HOLTER ANALYSIS WORKSTATION | Ge Medical Systems Information Technologies, Inc. | 2013-12-04 | 121 | 0 |
| K130626 | MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSI | Ge Medical Systems Information Technologies, Inc. | 2013-05-01 | 54 | 0 |
| K123996 | RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF | Ge Medical Systems Information Technologies, Inc. | 2013-04-09 | 104 | 0 |
| K130155 | MUSE CARDIOLOGY INFORMATION SYSTEM | Ge Medical Systems Information Technologies, Inc. | 2013-03-01 | 38 | 0 |
| K120125 | SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF | Ge Medical Systems Information Technologies, Inc. | 2012-10-03 | 260 | 0 |
| K110132 | MUSE CARDIOLOGY INFORMATION SYSTEM | Ge Medical Systems Information Technologies, Inc. | 2011-05-25 | 127 | 0 |
| K103765 | MAC 600 RESTING ECG ANALYSIS SYSTEM | Ge Medical Systems Information Technologies, Inc. | 2011-05-17 | 145 | 0 |
| K110266 | MAC 5500 HD, MAC 3500 | Ge Medical Systems Information Technologies, Inc. | 2011-04-29 | 91 | 0 |
| K103432 | UNITY NETWORK ID | Ge Medical Systems Information Technologies, Inc. | 2010-12-17 | 24 | 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