Cleared Traditional

K873031 - STARKEY MODEL P1 MODULE

K873031 is an FDA 510(k) clearance for STARKEY MODEL P1 MODULE, manufactured by Starkey Laboratories, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRB cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K873031 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
188d
Days
Class 1
Risk

K873031 is an FDA 510(k) clearance for the STARKEY MODEL P1 MODULE. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on February 8, 1988 after a review of 188 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Starkey Laboratories, Inc. devices

FDA 510(k) Submission Details - K873031

510(k) Number K873031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date February 08, 1988
Days to Decision 188 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 90d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

LRB Device Classification - Class 1, General Controls

Product Code LRB Face Plate Hearing Aid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
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 - LRB Face Plate Hearing Aid

All 18
Devices cleared under the same product code (LRB) and FDA review panel - the closest regulatory comparables to K873031.
SILVER L MODULE, ITE
K933046 · Electone, Inc. · Aug 1993
FACEPLATE ITE HEARING AID MODEL TCA
K910900 · Telex Communications, Inc. · May 1991
FACEPLATE ITE HEARING AID MODEL 28A
K910901 · Telex Communications, Inc. · May 1991
AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR
K872645 · Richards Medical Co., Inc. · Dec 1987
SERVICE MASTER (IMPULSE)
K873300 · Richards Medical Co., Inc. · Dec 1987
FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10
K862768 · Maico Hearing Instruments, Inc. · Aug 1986