Cleared Traditional

K030572 - HENKE SASS WOLF OF AMERICA NASOPHARYNGO...

K030572 is an FDA 510(k) clearance for HENKE SASS WOLF OF AMERICA NASOPHARYNGO..., manufactured by Henke Sass Wolf of America, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K030572 · Henke Sass Wolf of America, Inc. · Ear, Nose, Throat device
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Apr 2003
Decision
36d
Days
Class 2
Risk

K030572 is an FDA 510(k) clearance for the HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Henke Sass Wolf of America, Inc. (Flemington, US). The FDA issued a Cleared decision on April 1, 2003 after a review of 36 days - a notably fast clearance 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: 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 Henke Sass Wolf of America, Inc. devices

FDA 510(k) Submission Details - K030572

510(k) Number K030572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2003
Decision Date April 01, 2003
Days to Decision 36 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
53d faster than avg
Panel avg: 89d · This submission: 36d
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 K030572.
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
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073 · Olympus America, Inc. · May 2002