Cleared Traditional

K813003 - P.P.P. TREATMENT CABINET

K813003 is an FDA 510(k) clearance for P.P.P. TREATMENT CABINET, manufactured by Precision Professional Products. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K813003 · Precision Professional Products · Ear, Nose, Throat device
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Nov 1981
Decision
11d
Days
Class 1
Risk

K813003 is an FDA 510(k) clearance for the P.P.P. TREATMENT CABINET. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Precision Professional Products (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 11 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 Precision Professional Products devices

FDA 510(k) Submission Details - K813003

510(k) Number K813003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1981
Decision Date November 06, 1981
Days to Decision 11 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
78d faster than avg
Panel avg: 89d · This submission: 11d
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 30
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K813003.
AUDIOSCOPE #23000 W/71123 CHARGING STAND
K831709 · Welch Allyn, Inc. · Jun 1983
CONPHAR OTOSCOPE/OPTHALMASCOPE
K813299 · Conphar, Inc. · Jan 1982
CONPHAR OTOSCOPE
K813305 · Conphar, Inc. · Jan 1982
ILLIMINATOR, MODEL 265 NASAL
K782142 · Welch Allyn, Inc. · Jan 1979
OTOSCOPE, DIAG. MODELS 20100 & 20200
K781029 · Welch Allyn, Inc. · Jun 1978
OTOSCOPE/ILLUMINATOR, MODEL #21100
K770769 · Welch Allyn, Inc. · Apr 1977