Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GE Healthcare Finland Oy · Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
157 daysmedian FDA review time
260 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARES | GE Healthcare Finland Oy | 2023-04-06 | 134 | 3 |
| K213181 | CARESCAPE B650, E-musb | GE Healthcare Finland Oy | 2022-04-13 | 196 | 2 |
| K213336 | Carescape B850, E-musb | GE Healthcare Finland Oy | 2022-04-13 | 189 | 1 |
| K213363 | CARESCAPE B450, E-musb | GE Healthcare Finland Oy | 2022-04-13 | 183 | 1 |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAi | GE Healthcare Finland Oy | 2021-10-21 | 185 | 0 |
| K191323 | Carescape B850 | GE Healthcare Finland Oy | 2020-01-29 | 259 | 1 |
| K191249 | CARESCAPE B450 | GE Healthcare Finland Oy | 2020-01-24 | 260 | 0 |
| K191322 | E-EEGX, N-EEGX | GE Healthcare Finland Oy | 2020-01-22 | 252 | 0 |
| K191149 | CARESCAPE B650 | GE Healthcare Finland Oy | 2020-01-21 | 266 | 2 |
| K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCA | GE Healthcare Finland Oy | 2019-05-01 | 145 | 4 |
| K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCA | GE Healthcare Finland Oy | 2017-08-17 | 134 | 4 |
| K143676 | B40i Patient Monitor | GE Healthcare Finland Oy | 2015-07-31 | 219 | 0 |
| K150245 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCA | GE Healthcare Finland Oy | 2015-07-17 | 165 | 4 |
| K132528 | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES | GE Healthcare Finland Oy | 2014-01-16 | 157 | 0 |
| K132533 | CARESCAPE MONITOR B450 | GE Healthcare Finland Oy | 2013-12-04 | 114 | 1 |
| K132696 | TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE | GE Healthcare Finland Oy | 2013-09-27 | 29 | 0 |
| K131223 | CARESCAPE MONITOR B650 | GE Healthcare Finland Oy | 2013-08-28 | 120 | 3 |
| K131414 | CARESCAPE MONITOR B850 | GE Healthcare Finland Oy | 2013-08-28 | 104 | 3 |
| K123195 | CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND A | GE Healthcare Finland Oy | 2013-02-28 | 140 | 4 |
| K103802 | TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SE | GE Healthcare Finland Oy | 2011-08-02 | 217 | 0 |
| K102389 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2011-06-10 | 291 | 0 |
| K102239 | CARESCAPE MONITOR B650 | GE Healthcare Finland Oy | 2010-10-18 | 70 | 7 |
| K101871 | TRUSIGNAL SPO2 FINGERTIP SENSOR | GE Healthcare Finland Oy | 2010-10-04 | 90 | 0 |
| K093881 | TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRU | GE Healthcare Finland Oy | 2010-03-12 | 84 | 4 |
| K092680 | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7 | GE Healthcare Finland Oy | 2009-09-23 | 22 | 0 |
| K090892 | GE DATEX-OHMEDA S/5 ADU CARESTATION | GE Healthcare Finland Oy | 2009-04-30 | 30 | 1 |
| K083098 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2009-04-01 | 166 | 0 |
| K081941 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2008-08-07 | 30 | 0 |
| K081870 | MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO | GE Healthcare Finland Oy | 2008-07-31 | 30 | 0 |
| K071097 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2007-10-10 | 175 | 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