Cleared Traditional

K070648 - THE INHIBITOR, MODEL 001

K070648 is an FDA 510(k) clearance for THE INHIBITOR, manufactured by Melmedtronics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K070648 · Melmedtronics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
113d
Days
Class 2
Risk

K070648 is an FDA 510(k) clearance for the THE INHIBITOR, MODEL 001. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Melmedtronics, Inc. (Hurst, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - 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 Melmedtronics, Inc. devices

FDA 510(k) Submission Details - K070648

510(k) Number K070648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2007
Decision Date June 29, 2007
Days to Decision 113 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 90d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLW Device Classification - Class 2, Special Controls

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - KLW Masker, Tinnitus

All 57
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K070648.
ZEN PROGRAM (MIND 440 HEARING AID)
K080955 · Widex Hearing Aid Co., Inc. · Jun 2008
TINNITUS SOUND GENERATOR MODULE
K073636 · Gn Resound A/S · Mar 2008
CUSTOMIZED SOUND THERAPY (CST)
K070599 · Tinnitus Otosound Products, LLC · Jul 2007
TRANQUIL TRI-BTE
K061459 · General Hearing Instruments, Inc. · Jun 2006
TINNITUS PHASE-OUT
K061111 · Tinnitus Control, Inc. · May 2006
NEUROMONICS TINNITUS TREATMENT
K043274 · Neuromonics Pty, Ltd. · Jan 2005