FDA product code · Gastroenterology and urology

Endoscopic Bite Block

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

MNKClass I21 CFR 876.1500510(k) exempt6 decisions since 19900 recalls

FDA lists MNK as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 6 FDA decisions since 1990. No recall names this code. The most-cited predicate is K914978, named by 2 later devices.

To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.

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, gastroenterology and urology panel

Twenty years of MNK 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 · MNK

FDA has decided no MNK device since 2007.

Median 510(k) review, days · MNK

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

Recalls per year · MNK

No recall names MNK since 2007.

Adverse event reports per year · MNK

39in 2025

2007high 39 (2025) · low 0 (2007)2025

MAUDE reports naming product code MNK, 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	—	1
2013	—	0
2014	—	3
2015	—	2
2016	—	5
2017	—	5
2018	—	9
2019	—	16
2020	—	13
2021	—	15
2022	—	11
2023	—	4
2024	—	21
2025	—	39
2026	—	—

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

Planning a device in MNK? 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 876.1500.

FAL Panendoscope (Urethroscope)FBO Cystourethroscope NWB Endoscope, Accessories, Narrow Band Spectrum KGD Scissors For Cystoscope FCZ Tube, Smoke Removal, Endoscopic FDW Esophagoscope, Rigid, Gastro-Urology FGS Carrier, Sponge, Endoscopic GCM Endoscope, Rigid GCN Endoscope, Prism FGA Kit, Nephroscope FAM Sigmoidoscope And Accessories, Flexible/Rigid GDB Endoscope, Fiber Optic

Endoscopic Bite Block

Which predicates do MNK devices cite most?

What has FDA decided in MNK lately?

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