Cleared Traditional

K864962 - OBERTO MOUTH PROP

K864962 is the FDA 510(k) clearance for OBERTO MOUTH PROP by Medovations, Inc.. It is a Class 2 Neurology device (product code JXL) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K864962 · Medovations, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
59d
Days
Class 2
Risk

K864962 is an FDA 510(k) clearance for the OBERTO MOUTH PROP. Classified as Block, Bite (product code JXL), Class II - Special Controls.

Submitted by Medovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 19, 1987 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5070 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medovations, Inc. devices

Submission Details

510(k) Number K864962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date February 19, 1987
Days to Decision 59 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 148d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXL Block, Bite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXL Block, Bite

All 8
Devices cleared under the same product code (JXL) and FDA review panel - the closest regulatory comparables to K864962.
BITE BLOCK
K954352 · United States Endoscopy Group, Inc. · Jan 1996
PREMIER PROMAX BITE GUARD
K941856 · Premier Dental Products Co. · Apr 1995
BITE BLOCK
K924304 · United States Endoscopy Group, Inc. · Apr 1993
GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
K861893 · Hi Chem, Inc. · Jun 1986
DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR
K830090 · Hudson Oxygen Therapy Sales Co. · Feb 1983
JACKSON BITE BLOCKS
K822018 · Kelleher Corp. · Aug 1982