510(k) Report

FDA product code · Ear, nose and throat

Curette, Nasal

KAPClass I21 CFR 874.4420510(k) exempt1 decision since 19870 recalls

FDA lists KAP 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. 1 FDA decision since 1987. 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 KAP 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 · KAP

FDA has decided no KAP device since 2007.

Median 510(k) review, days · KAP

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

Recalls per year · KAP

No recall names KAP since 2007.

Adverse event reports per year · KAP

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2025

MAUDE reports naming product code KAP, 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—02
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 — KAP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KAP? 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 874.4420.