Cleared Traditional

K942265 - FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ...

K942265 is the FDA 510(k) clearance for FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ... by Vision-Sciences, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 592-day FDA review.

K942265 · Vision-Sciences, Inc. · Ear, Nose, Throat device
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Dec 1995
Decision
592d
Days
Class 2
Risk

K942265 is an FDA 510(k) clearance for the FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Vision-Sciences, Inc. (Natick, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 592 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 874.4760 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Vision-Sciences, Inc. devices

Submission Details

510(k) Number K942265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date December 22, 1995
Days to Decision 592 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
503d slower than avg
Panel avg: 89d · This submission: 592d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 83
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K942265.
KARL STORZ CONTACT MICRO-LARYNGOSCOPES
K963426 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
KSEA BIPOLAR GOAGULATING FORCEPS
K962396 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
KSEA UNIMAT PLUS
K962898 · KARL STORZ Endoscopy-America, Inc. · Aug 1996
OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS
K953771 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
GLANZ CARCINOMA GAUGE, KSEA
K954348 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
FNL-10P, FIBER NASOPARHYNGOSCOPE
K951196 · Pentax Precision Instrument Corp. · Apr 1995