Cleared Traditional

K942158 - AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K942158 · Wfr/Aquaplast Corp. · Ear, Nose, Throat device
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Jul 1994
Decision
87d
Days
Class 1
Risk

K942158 is an FDA 510(k) clearance for the AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS. Classified as Splint, Nasal (product code EPP), Class I - General Controls.

Submitted by Wfr/Aquaplast Corp. (Wyckoff, US). The FDA issued a Cleared decision on July 29, 1994 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5800 - 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 Wfr/Aquaplast Corp. devices

Submission Details

510(k) Number K942158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1994
Decision Date July 29, 1994
Days to Decision 87 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
2d faster than avg
Panel avg: 89d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EPP Splint, Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.