Cleared Traditional

K782115 - ASTRA-VAC

K782115 is an FDA 510(k) clearance for ASTRA-VAC, manufactured by Ab Astra. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K782115 · Ab Astra · General & Plastic Surgery device
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Feb 1979
Decision
36d
Days
Class 1
Risk

K782115 is an FDA 510(k) clearance for the ASTRA-VAC. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Ab Astra (Mchenry, US). The FDA issued a Cleared decision on February 1, 1979 after a review of 36 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 Ab Astra devices

FDA 510(k) Submission Details - K782115

510(k) Number K782115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date February 01, 1979
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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 K782115.
DAVOL/ABAMSON SILICONE SUMP DRAIN
K800081 · Davol, Inc. · Jan 1980
DOW CORNING/W RIGHT WOUND DRAINAGE SYS
K800014 · Dow Corning Corp. Healthcare Industries Materials · Jan 1980
CLOSED WOUND VACUUM DRAINAGE SYSTEM
K790654 · 3M Company · Apr 1979
ROUND SILICONE DRAIN
K782028 · Davol, Inc. · Dec 1978
FLAT SILICONE DRAIN
K782026 · Davol, Inc. · Dec 1978
PORTABLE CLOSED WOUND SUCTION EVACUATOR
K780848 · Biomet, Inc. · Aug 1978