Cleared Traditional

M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM (K951424) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951424 · M.E.R. Surgical Co. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
43d
Days
Class 2
Risk

K951424 is an FDA 510(k) clearance for the M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by M.E.R. Surgical Co. (Walnut, US). The FDA issued a Cleared decision on May 9, 1995 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4710 - 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 M.E.R. Surgical Co. devices

Submission Details

510(k) Number K951424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date May 09, 1995
Days to Decision 43 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 89d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOX Esophagoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4710
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - EOX Esophagoscope (flexible Or Rigid)

All 17
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K951424.
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
K051972 · KARL STORZ Endoscopy-America, Inc. · Aug 2005
PRISM ELECTROSCOPE
K953849 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES
K951395 · KARL STORZ Endoscopy-America, Inc. · May 1995
KARL STORZ BOUGIES, SOUNDS, DILATORS
K946331 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE
K945237 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
ESOPHAGOSCOPE AND ACCESSORIES
K943667 · KARL STORZ Endoscopy-America, Inc. · Aug 1994