Cleared Traditional

K920439 - OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE

K920439 is an FDA 510(k) clearance for OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE, manufactured by Omega Universal Technologies, Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K920439 · Omega Universal Technologies, Ltd. · Ear, Nose, Throat device
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Sep 1992
Decision
214d
Days
Class 2
Risk

K920439 is an FDA 510(k) clearance for the OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Omega Universal Technologies, Ltd. (Marlboro, US). The FDA issued a Cleared decision on September 4, 1992 after a review of 214 days - an extended review 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: 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 Omega Universal Technologies, Ltd. devices

FDA 510(k) Submission Details - K920439

510(k) Number K920439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1992
Decision Date September 04, 1992
Days to Decision 214 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
125d slower than avg
Panel avg: 89d · This submission: 214d
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 K920439.
NASAL/PARANASAL ENDOSCOPE
K930931 · Storz Instrument Co. · May 1993
ENDOSHEATH
K925421 · Vision-Sciences, Inc. · Jan 1993
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