Cleared Traditional

FNL-10P, FIBER NASOPARHYNGOSCOPE (K951196) - FDA 510(k) Clearance

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

K951196 · Pentax Precision Instrument Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
22d
Days
Class 2
Risk

K951196 is an FDA 510(k) clearance for the FNL-10P, FIBER NASOPARHYNGOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Miramar, US). The FDA issued a Cleared decision on April 7, 1995 after a review of 22 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 Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K951196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1995
Decision Date April 07, 1995
Days to Decision 22 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
67d faster than avg
Panel avg: 89d · This submission: 22d
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 62
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K951196.
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
KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE
K951201 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
KARL STORZ TELE-SCRUB
K950334 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
KARL STORZ VISCOUS FLUID INJECTION SET
K950603 · KARL STORZ Endoscopy-America, Inc. · Feb 1995