510(k) Report

FDA product code · Ear, nose and throat

Blower, Powder, Ent

KCLClass I21 CFR 874.5220510(k) exempt0 decisions0 recalls

FDA lists KCL as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 874.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 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, ear, nose and throat panel

Twenty years of KCL 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 · KCL

FDA has decided no KCL device since 2007.

Median 510(k) review, days · KCL

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

Recalls per year · KCL

No recall names KCL since 2007.

Adverse event reports per year · KCL

No MAUDE report names KCL 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 — KCL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KCL? 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 874.5220.

KCJ Applicator, EntEPN Pump, Nebulizer, ManualKCM Dropper, EntJPW Pump, Nebulizer, Electrically PoweredKCP Syringe, EntLRD Applicator, Ent DrugKCN Ear WickKCO Nasal Spray, Ent Delivery