Cleared Traditional

VIR-A-VAC EMPTY (K882315) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882315 · Viratec Corp. · General Hospital
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Sep 1988
Decision
115d
Days
Class 2
Risk

K882315 is an FDA 510(k) clearance for the VIR-A-VAC EMPTY. Classified as Tubing, Noninvasive (product code GAZ), Class II - Special Controls.

Submitted by Viratec Corp. (Tuckahoe, US). The FDA issued a Cleared decision on September 26, 1988 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Viratec Corp. devices

Submission Details

510(k) Number K882315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1988
Decision Date September 26, 1988
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 129d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAZ Tubing, Noninvasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.