510(k) Report

FDA applicant

GE Healthcare Finland Oy

Helsinki, FI32 decisions2007–202629 recalls

FDA records 32 decisions for GE Healthcare Finland Oy (Helsinki, FI) from 2007 to 2026: 32 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and BSZ (Gas-Machine, Anesthesia). Since 2016 its 510(k)s took a median of 188 days from receipt to decision, against 196 for FDA’s reviews in the same codes and years. Its devices cite 51 predicates, 25 of them its own earlier devices. 29 recalls are linked to its devices, 8 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided GE Healthcare Finland Oy’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 12008: 22009: 32010: 32011: 22013: 52014: 12015: 22017: 12019: 12020: 42021: 12022: 32023: 12026 (partial year): 2
2007high 5 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2025

2011: 22012: 12013: 22014: 42015: 12018: 42019: 4, 4 Class I2023: 5, 4 Class I2024: 52025: 1
2007high 5 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — GE Healthcare Finland Oy by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like GE Healthcare Finland Oy’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)15decisions
  • BSZGas-Machine, Anesthesia5decisions
  • DQAOximeter5decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase4decisions
  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase1decision
  • DXGComputer, Diagnostic, Pre-Programmed, Single-Function1decision

Also: OLT (1).

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 188 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 196 days; 5 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 51 predicates; 25 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 times; 25 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K102239Carescape Monitor B650GE Healthcare Finland Oy · 20105cite it
  • K071097Navigator Applications SuiteGE Healthcare Finland Oy · 20074cite it
  • K081941Navigator Applications SuiteGE Healthcare Finland Oy · 20083cite it
  • K123195Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesGE Healthcare Finland Oy · 20132cite it
  • K131223Carescape Monitor B650GE Healthcare Finland Oy · 20132cite it
  • K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy · 20102cite it

What has FDA decided for it lately?

  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)GE Healthcare Finland Oy · 20233 recalls
  • K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy · 20222 recalls
  • K213336Carescape B850, E-musbGE Healthcare Finland Oy · 20221 recall
  • K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy · 20221 recall
  • K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and…GE Healthcare Finland Oy · 2021
  • K191323Carescape B850GE Healthcare Finland Oy · 20201 recall

All 32 as GE Healthcare Finland Oy →

What has been recalled?

29 recalls linked to its devices; the latest:

  • K213363Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or…Sep 26, 2025Class II
  • K191323CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c)…Apr 5, 2024Class II
  • K223531CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c)…Apr 5, 2024Class II
  • K191149CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010…Apr 5, 2024Class II
  • K223531CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c)…Apr 5, 2024Class II
  • K191149CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2)…Apr 5, 2024Class II