Cleared Traditional

VERSA-VIAL (K920177) - FDA 510(k) Clearance

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

K920177 · Bioteque America, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 1992
Decision
181d
Days
Class 2
Risk

K920177 is an FDA 510(k) clearance for the VERSA-VIAL. Classified as Actuator, Syringe, Injector Type (product code DQF), Class II - Special Controls.

Submitted by Bioteque America, Inc. (Levittown, US). The FDA issued a Cleared decision on July 13, 1992 after a review of 181 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1670 - 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 Bioteque America, Inc. devices

Submission Details

510(k) Number K920177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1992
Decision Date July 13, 1992
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 129d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQF Actuator, Syringe, Injector Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1670
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.