GE Healthcare Finland Oy: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “GE Healthcare Finland Oy” (first 2007, latest 2026), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 161 days. Since 2017 the median was 189 days, against 203 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 5 | 114 |
| 2014 | 1 | 157 |
| 2015 | 2 | 192 |
| 2016 | 0 | — |
| 2017 | 1 | 134 |
| 2018 | 0 | — |
| 2019 | 1 | 145 |
| 2020 | 4 | 260 |
| 2021 | 1 | 185 |
| 2022 | 3 | 189 |
| 2023 | 1 | 134 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 196 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name GE Healthcare Finland Oy took a median 189 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 203 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 15 | 15 |
| BSZ | Gas-Machine, Anesthesia | 5 | 5 |
| DQA | Oximeter | 5 | 5 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 4 | 4 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 | 1 |
Review panels
- Cardiovascular (16)
- Anesthesiology (15)
- Neurology (1)
Most recent GE Healthcare Finland Oy 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M | MHX | 2026-09-01 | 186 |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display | MHX | 2026-08-28 | 207 |
| K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) | MHX | 2023-04-06 | 134 |
| K213363 | CARESCAPE B450, E-musb | MHX | 2022-04-13 | 183 |
| K213336 | Carescape B850, E-musb | MHX | 2022-04-13 | 189 |
| K213181 | CARESCAPE B650, E-musb | MHX | 2022-04-13 | 196 |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories | CCK | 2021-10-21 | 185 |
| K191323 | Carescape B850 | MHX | 2020-01-29 | 259 |
| K191249 | CARESCAPE B450 | MHX | 2020-01-24 | 260 |
| K191322 | E-EEGX, N-EEGX | OLT | 2020-01-22 | 252 |
22 earlier clearances. See the full list in Caduvo.
Recalls
22 product recalls in 5 recall events; 19 initiated in the last five years. Most recent: 2025-09-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under GE Healthcare Finland Oy?
FDA lists 32 510(k) clearances under the applicant name “GE Healthcare Finland Oy” (first 2007, latest 2026), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by GE Healthcare Finland Oy?
The median time from FDA receipt to decision across 510(k)s cleared under the name GE Healthcare Finland Oy is 161 days. Since 2017: 189 days, versus 203 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under GE Healthcare Finland Oy?
The most frequent FDA product codes under this applicant name are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 15); BSZ (Gas-Machine, Anesthesia, 5); DQA (Oximeter, 5).
Next steps
- See all 32 GE Healthcare Finland Oy clearances with predicates and recalls
- Run predicate analysis for product code MHX, GE Healthcare Finland Oy's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.