Cleared Traditional

K950086 - PEDIA PALS

K950086 is an FDA 510(k) clearance for PEDIA PALS, manufactured by Pedia Pals, Inc.. The device is a Class 1 General & Plastic Surgery device with product code EPY cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K950086 · Pedia Pals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
28d
Days
Class 1
Risk

K950086 is an FDA 510(k) clearance for the PEDIA PALS, INCORPORATED. Classified as Speculum, Ent (product code EPY), Class I - General Controls.

Submitted by Pedia Pals, Inc. (Columbus, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.1800 - the FDA general and plastic surgery 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 Pedia Pals, Inc. devices

FDA 510(k) Submission Details - K950086

510(k) Number K950086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date February 07, 1995
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

EPY Device Classification - Class 1, General Controls

Product Code EPY Speculum, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.1800
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.

Regulatory Peers - EPY Speculum, Ent

All 11
Devices cleared under the same product code (EPY) and FDA review panel - the closest regulatory comparables to K950086.
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