Cleared Traditional

K895245 - FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE

K895245 is an FDA 510(k) clearance for FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE, manufactured by Optimed Technologies, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K895245 · Optimed Technologies, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
88d
Days
Class 2
Risk

K895245 is an FDA 510(k) clearance for the FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Optimed Technologies, Inc. (Irvine, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 88 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 Optimed Technologies, Inc. devices

FDA 510(k) Submission Details - K895245

510(k) Number K895245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1989
Decision Date November 17, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 89d · This submission: 88d
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 K895245.
DISPOSABLE PROTECTIVE SHEATH
K921244 · Vision-Sciences, Inc. · Oct 1992
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
K921707 · Pentax Precision Instrument Corp. · Jul 1992
FLEXIBLE NASOPHARYNGOSCOPE
K896297 · Jedmed Instrument Co. · Jan 1990
ENDOSCOPES FOR SINUS SURGERY
K874215 · Richards Medical Co., Inc. · Jan 1988