510(k) Report

FDA product code · Radiology

System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)

KYAClass I21 CFR 884.2982510(k) required5 decisions since 19820 recalls

5 FDA decisions since 1982. No recall names this code.

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, radiology panel

Twenty years of KYA 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.

FDA decisions per year · KYA

FDA has decided no KYA device since 2007.

Median 510(k) review, days · KYA

Too few KYA 510(k)s in any year since 2007 to give a median.

Recalls per year · KYA

No recall names KYA since 2007.

Adverse event reports per year · KYA

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code KYA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—
FIG. 1 — KYA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KYA? 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 884.2982.