Cleared Traditional

K833939 - NITROGLYCERIN I.V. ADMINISTRATION SET

K833939 is an FDA 510(k) clearance for NITROGLYCERIN I.V. ADMINISTRATION SET, manufactured by Critikon Company, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K833939 · Critikon Company, LLC · General Hospital
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Feb 1984
Decision
98d
Days
Class 2
Risk

K833939 is an FDA 510(k) clearance for the NITROGLYCERIN I.V. ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Critikon Company, LLC (Walker, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 98 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K833939

510(k) Number K833939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1983
Decision Date February 21, 1984
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 129d · This submission: 98d
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 540
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K833939.
HARVARD ANTI-REFLUX Y-SET
K840760 · C.R. Bard, Inc. · Apr 1984
QUIK LOK
K840878 · Abbott Laboratories · Mar 1984
LOPEZ LOCK
K840273 · Icu Medical, Inc. · Mar 1984
INTRAVENOUS FILTER SET
K834130 · Tri-Med, Inc. · Jan 1984
CONTINU-FLO SOLUTION ADMIN. 2C9102
K834289 · Travenol Laboratories, S.A. · Jan 1984
SOLUTION ADMIN. SET 2C9096 W/10 PVC
K832284 · Travenol Laboratories, S.A. · Dec 1983