Cleared Traditional

SPARTA BRONCHIAL BRUSH (K781365) - FDA 510(k) Clearance

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

K781365 · Sparta Instrument Corp. · Ear, Nose, Throat device
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Aug 1978
Decision
7d
Days
Class 2
Risk

K781365 is an FDA 510(k) clearance for the SPARTA BRONCHIAL BRUSH. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Sparta Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - 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 Sparta Instrument Corp. devices

Submission Details

510(k) Number K781365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1978
Decision Date August 14, 1978
Days to Decision 7 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
82d faster than avg
Panel avg: 89d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTI Bronchoscope Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
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 - KTI Bronchoscope Accessory

All 32
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