Cleared Traditional

K932131 - MID LABS TWIN ILLUMINATOR

K932131 is an FDA 510(k) clearance for MID LABS TWIN ILLUMINATOR, manufactured by Medical Instrument Development Laboratories, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EQH cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K932131 · Medical Instrument Development Laboratories, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
333d
Days
Class 1
Risk

K932131 is an FDA 510(k) clearance for the MID LABS TWIN ILLUMINATOR. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on April 1, 1994 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - 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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K932131

510(k) Number K932131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1993
Decision Date April 01, 1994
Days to Decision 333 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
243d slower than avg
Panel avg: 90d · This submission: 333d
Pathway characteristics
Predicate-based equivalence.

EQH Device Classification - Class 1, General Controls

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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 - EQH Source, Carrier, Fiberoptic Light

All 32
Devices cleared under the same product code (EQH) and FDA review panel - the closest regulatory comparables to K932131.
GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT
K941661 · Gm Engineering, Inc. · Aug 1994
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
K941662 · Gm Engineering, Inc. · Jul 1994
SAPHIRE PLUS SURGICAL MIRROR
K934911 · San Diego Swiss Machining, Inc. · Jun 1994
ASPIRATING ENDO OCULAR PROBE
K930123 · Surgical Technologies, Inc. · Feb 1994
FIBEROPTIC LIGHTSOURCES AND CARRIERS
K933145 · Electro Fiberoptics Corp. · Sep 1993
THROAT-A-SCOPE
K923227 · Truphatek, Ltd. · Dec 1992