510(k) Report

FDA applicant

Analog Devices

Wilmington, MA3 decisions2023–20260 recalls

FDA records 3 decisions for Analog Devices (Wilmington, MA) from 2023 to 2026: 3 510(k) clearances. All are in product code MWI (Monitor, Physiological, Patient (Without…). Since 2016 its 510(k)s took a median of 219 days from receipt to decision, against 239 for FDA’s reviews in the same codes and years. No recall is linked to its devices.

FDA’s records also spell it “Analog Devices, Inc.”.

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 Analog Devices’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 12026 (partial year): 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Analog Devices by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 219 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 239 days; 3 of its 3 were faster than that.

What has FDA decided for it lately?

  • K260801Sensinel Cardiopulmonary Management (CPM) SystemAnalog Devices · 2026
  • K243216Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)Analog Devices · 2024
  • K231086CPM SystemAnalog Devices, Inc. · 2023

All 2 as Analog Devices →The one decision as Analog Devices, Inc. →