510(k) Report

FDA product code · Microbiology

Antisera, All Types, Klebsiella Spp.

GTCClass I21 CFR 866.3340510(k) exempt1 decision since 19830 recalls

FDA lists GTC as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1983. 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, microbiology panel

Twenty years of GTC 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 · GTC

FDA has decided no GTC device since 2007.

Median 510(k) review, days · GTC

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

Recalls per year · GTC

No recall names GTC since 2007.

Adverse event reports per year · GTC

No MAUDE report names GTC since 2007.

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—00
20240—00
20250—00
20260—0—
FIG. 1 — GTC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GTC? 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

What has FDA decided in GTC lately?

  • K830276Securet Drape & Instrument Retainer/InclRitmed, Inc. · 1983

The one GTC decision →

Related product codes

Other codes under 21 CFR 866.3340.

GTB Antisera, Fluorescent, All Types, Klebsiella…