510(k) Report

FDA product code · Ophthalmic

Headlamp, Operating, Battery-Operated

HPPClass I21 CFR 886.4335510(k) exempt0 decisions0 recalls

FDA lists HPP as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 886.9 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, ophthalmic panel

Twenty years of HPP 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 · HPP

FDA has decided no HPP device since 2007.

Median 510(k) review, days · HPP

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

Recalls per year · HPP

No recall names HPP since 2007.

Adverse event reports per year · HPP

2in 2025

2019: 12020: 22021: 22022: 12023: 22024: 12025: 2
2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code HPP, 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—01
20200—02
20210—02
20220—01
20230—02
20240—01
20250—02
20260—0—
FIG. 1 — HPP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HPP? 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 886.4335.

FSR Light, Headband, SurgicalHPQ Headlamp, Operating, Ac-PoweredFCT Headlight, Fiberoptic Focusing