FDA product code · Dental

Absorber, Saliva, Paper

Name: FDA decisions, review times, recalls and adverse event reports for product code KHR
Creator: 510(k) Report

KHRClass I21 CFR 872.6050510(k) exempt10 decisions since 19770 recalls

FDA lists KHR as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 872.9 applies, such as a new intended use or a different fundamental technology. 10 FDA decisions since 1977. 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, dental panel

Twenty years of KHR 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 · KHR

FDA has decided no KHR device since 2007.

Median 510(k) review, days · KHR

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

Recalls per year · KHR

No recall names KHR since 2007.

Adverse event reports per year · KHR

1in 2019

2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code KHR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	1
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — KHR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KHR? 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

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