Cleared Traditional

K920177 - VERSA-VIAL

K920177 is an FDA 510(k) clearance for VERSA-VIAL, manufactured by Bioteque America, Inc.. The device is a Class 2 General Hospital device with product code DQF cleared through the Traditional 510(k) pathway after a 181-day FDA review.

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

FDA 510(k) Submission Details - K920177

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.

DQF Device Classification - Class 2, Special Controls

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.