Cleared Traditional

K874081 - ENTERSCAN (FDA 510(k) Clearance)

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

K874081 · Pie Data Medical BV · Ear, Nose, Throat device
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Dec 1987
Decision
85d
Days
Class 2
Risk

K874081 is an FDA 510(k) clearance for the ENTERSCAN. Classified as Ultrasound, Sinus (product code LWI), Class II - Special Controls.

Submitted by Pie Data Medical BV (Maastricht 6227 Aj, NL). The FDA issued a Cleared decision on December 31, 1987 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 892.1560 - 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 Pie Data Medical BV devices

Submission Details

510(k) Number K874081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1987
Decision Date December 31, 1987
Days to Decision 85 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
4d faster than avg
Panel avg: 89d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LWI Ultrasound, Sinus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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.