Cleared Traditional

K030857 - MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS A...

K030857 is an FDA 510(k) clearance for MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS A..., manufactured by Mahe Intl., Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K030857 · Mahe Intl., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
212d
Days
Class 2
Risk

K030857 is an FDA 510(k) clearance for the MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND .... Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Mahe Intl., Inc. (Nashville, US). The FDA issued a Cleared decision on October 16, 2003 after a review of 212 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - 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 Mahe Intl., Inc. devices

FDA 510(k) Submission Details - K030857

510(k) Number K030857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2003
Decision Date October 16, 2003
Days to Decision 212 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 89d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOB Device Classification - Class 2, Special Controls

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
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 - EOB Nasopharyngoscope (flexible Or Rigid)

All 106
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K030857.
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
K052452 · Olympus Medical Systems Corporation · Sep 2005
VISION-SCIENCES ENT-3000 SCOPE
K050972 · Vision-Sciences, Inc. · Apr 2005
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
K040984 · Vision-Sciences, Inc. · Apr 2004
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
K031790 · Vision-Sciences, Inc. · Jul 2003
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM
K024095 · Vision-Sciences, Inc. · Jan 2003
VISION SCIENCES ENDOSHEATH SYSTEM
K012543 · Vision-Sciences, Inc. · Jul 2002