Cleared Traditional

K853295 - EMODREN EXCHANGEABLE PLASTIC BELLOWS

K853295 is an FDA 510(k) clearance for EMODREN EXCHANGEABLE PLASTIC BELLOWS, manufactured by Parexel Intl. Corp.. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K853295 · Parexel Intl. Corp. · General & Plastic Surgery device
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Aug 1985
Decision
14d
Days
Class 1
Risk

K853295 is an FDA 510(k) clearance for the EMODREN EXCHANGEABLE PLASTIC BELLOWS. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Parexel Intl. Corp. (Cambridge, US). The FDA issued a Cleared decision on August 20, 1985 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4680 - 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 Parexel Intl. Corp. devices

FDA 510(k) Submission Details - K853295

510(k) Number K853295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1985
Decision Date August 20, 1985
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

GCY Device Classification - Class 1, General Controls

Product Code GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4680
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 - GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

All 52
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K853295.
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BARD PARKER 150CC BELLOWS RESERVOIR
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ECONOMY 400 CWS WITH PVC DRAINS
K851084 · C.R. Bard, Inc. · Jun 1985
CONCEPT C-VAC
K842710 · Concept, Inc. · Oct 1984
DISP. YANKAVER SURG. SUCTION INSTRUMENT
K830123 · Narco Scientific · Jun 1983