510(k) Report

FDA product code · Ear, nose and throat

Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

NUPClass II21 CFR 880.5045510(k) required8 decisions since 20050 recalls

8 FDA decisions since 2005. 510(k) reviews decided 2021–2025 took a median of 272 days (half between 271 and 273). No recall names this code. The most-cited predicate is K042610, named by 2 later devices.

THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.

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 NUP 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 · NUP

1in 2022

2012: 12013: 12014: 12017: 12021: 12022: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUP

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

Recalls per year · NUP

No recall names NUP since 2007.

Adverse event reports per year · NUP

1in 2024

2020: 12024: 1
2007high 1 (2020) · low 0 (2007)2025

MAUDE reports naming product code NUP, 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
20121—00
20131—00
20141—00
20150—00
20160—00
20171—00
20180—00
20190—00
20200—01
20211—00
20221—00
20230—00
20240—01
20250—00
20260—0—
FIG. 1 — NUP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NUP? 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 880.5045.