FDA product code · General hospital

Stationary Infrared Thermometer

Name: FDA decisions, review times, recalls and adverse event reports for product code SDW
Creator: 510(k) Report

SDWClass II21 CFR 880.2910510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

A stationary infrared thermometer is a free-standing or mounted clinical electronic thermometer indicated to measure a person’s body temperature. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of SDW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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

Planning a device in SDW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 880.2910.

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