Cleared Traditional

K862661 - D.L. SCOPE(R) OTOSCOPE

K862661 is an FDA 510(k) clearance for D.L. SCOPE OTOSCOPE, manufactured by North American Medical Products, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K862661 · North American Medical Products, Inc. · Ear, Nose, Throat device
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Aug 1986
Decision
25d
Days
Class 1
Risk

K862661 is an FDA 510(k) clearance for the D.L. SCOPE(R) OTOSCOPE. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by North American Medical Products, Inc. (Loudonville, US). The FDA issued a Cleared decision on August 8, 1986 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4770 - the FDA ear, nose and throat 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 North American Medical Products, Inc. devices

FDA 510(k) Submission Details - K862661

510(k) Number K862661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1986
Decision Date August 08, 1986
Days to Decision 25 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 90d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

ERA Device Classification - Class 1, General Controls

Product Code ERA Otoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4770
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ERA Otoscope

All 37
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K862661.
STARKEY LABORATORIES OTOSCOPE
K922752 · Starkey Laboratories, Inc. · Sep 1992
VIDEO OTOSCOPE
K904802 · Jedmed Instrument Co. · Jan 1991
TYMPANOSCOPE
K896274 · Jedmed Instrument Co. · Jan 1990
I22 INITIALES
K862621 · Oticon Corp. · Aug 1986
I81 CITE
K862624 · Oticon Corp. · Aug 1986
1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B
K851745 · Artiberia · Aug 1985