Cleared Traditional

K873031 - STARKEY MODEL P1 MODULE

K873031 is the FDA 510(k) clearance for STARKEY MODEL P1 MODULE by Starkey Laboratories, Inc.. It is a Class 1 Ear, Nose, Throat device (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

Submission Details

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
99d slower than avg
Panel avg: 89d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 13
Devices cleared under the same product code (LRB) and FDA review panel - the closest regulatory comparables to K873031.
SILVER LD MODULE, ITE
K933044 · Electone, Inc. · Aug 1993
SILVER RECHARGEABLE MODULE, ITE
K933045 · Electone, Inc. · Aug 1993
SILVER L MODULE, ITE
K933046 · Electone, Inc. · Aug 1993
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