Cleared Traditional

K790077 - BIOSTIL # 3884

K790077 is an FDA 510(k) clearance for BIOSTIL # 3884, manufactured by Venospital, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K790077 · Venospital, Inc. · General Hospital
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Apr 1979
Decision
109d
Days
Class 2
Risk

K790077 is an FDA 510(k) clearance for the BIOSTIL # 3884. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Venospital, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 30, 1979 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Venospital, Inc. devices

FDA 510(k) Submission Details - K790077

510(k) Number K790077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1979
Decision Date April 30, 1979
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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.

Regulatory Peers - FPA Set, Administration, Intravascular

All 812
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K790077.
SURFLO INJECTION PLUG
K791173 · Terumo America, Inc. · Jul 1979
INTRAVASCULAR ADMINISTRATION SET
K790582 · Y · May 1979
CUSTOM TUBING SETS
K790604 · Norton Performance Plastics Corp. · May 1979
T-CONNECTOR
K790408 · Medex, Inc. · Apr 1979
EPIC D215
K790574 · National Patent Development Corp. · Apr 1979
IV ADMINISTRATION SET WITH BACKCHECK
K790062 · National Patent Development Corp. · Apr 1979