Cleared Traditional

K833311 - NITROGLYCERINE CONTAINER (FDA 510(k) Clearance)

Class I General Hospital device.

K833311 · Apothecary Products, Inc. · General Hospital
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Feb 1984
Decision
131d
Days
Class 1
Risk

K833311 is an FDA 510(k) clearance for the NITROGLYCERINE CONTAINER. Classified as Dispenser, Solid Medication (product code NXB), Class I - General Controls.

Submitted by Apothecary Products, Inc. (Burnsville, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 131 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5050 - 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 Apothecary Products, Inc. devices

Submission Details

510(k) Number K833311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1983
Decision Date February 04, 1984
Days to Decision 131 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
2d slower than avg
Panel avg: 129d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NXB Dispenser, Solid Medication
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
Definition A Solid Medication Dispenser Is A Device Intended For Medical Purposes That Is Used To Issue Solid (pills) Medication.
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.