Cleared Traditional

K921244 - DISPOSABLE PROTECTIVE SHEATH

K921244 is the FDA 510(k) clearance for DISPOSABLE PROTECTIVE SHEATH 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 204-day FDA review.

K921244 · Vision-Sciences, Inc. · Ear, Nose, Throat device
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Oct 1992
Decision
204d
Days
Class 2
Risk

K921244 is an FDA 510(k) clearance for the DISPOSABLE PROTECTIVE SHEATH. 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 October 6, 1992 after a review of 204 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 Vision-Sciences, Inc. devices

Submission Details

510(k) Number K921244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date October 06, 1992
Days to Decision 204 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
115d slower than avg
Panel avg: 89d · This submission: 204d
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 K921244.
FORCEPS, PUNCHES, SCISSORS
K943074 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY
K932988 · Smith & Nephew Richards, Inc. · Jul 1993
NASAL/PARANASAL ENDOSCOPE
K930931 · Storz Instrument Co. · May 1993
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