Cleared Traditional

K945081 - TRANSTYMPANIC ENDOSCOPE

K945081 is an FDA 510(k) clearance for TRANSTYMPANIC ENDOSCOPE, manufactured by Endooptiks, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K945081 · Endooptiks, Inc. · Ear, Nose, Throat device
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Mar 1995
Decision
140d
Days
Class 2
Risk

K945081 is an FDA 510(k) clearance for the TRANSTYMPANIC ENDOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Endooptiks, Inc. (Little Silver, US). The FDA issued a Cleared decision on March 6, 1995 after a review of 140 days - within the typical 510(k) review window.

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 Endooptiks, Inc. devices

FDA 510(k) Submission Details - K945081

510(k) Number K945081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1994
Decision Date March 06, 1995
Days to Decision 140 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
51d slower than avg
Panel avg: 89d · This submission: 140d
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 K945081.
GLANZ CARCINOMA GAUGE, KSEA
K954348 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
FNL-10P, FIBER NASOPARHYNGOSCOPE
K951196 · Pentax Precision Instrument Corp. · Apr 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
KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS
K950338 · KARL STORZ Endoscopy-America, Inc. · Feb 1995