Cleared Traditional

RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET (K873729) - FDA 510(k) Clearance

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

K873729 · Critikon Company, LLC · General Hospital
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Dec 1987
Decision
105d
Days
Class 2
Risk

K873729 is an FDA 510(k) clearance for the RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 105 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

Submission Details

510(k) Number K873729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1987
Decision Date December 29, 1987
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 239
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K873729.
VENOVALVE(TM)
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SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH
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A SERIES OF 7 INCH CONTINUOUS INFUSION SETS
K874403 · Quinton, Inc. · Dec 1987
CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE
K873894 · Travenol Laboratories, S.A. · Nov 1987
THE GRIPPER(TM) PORT-A-CATH NEEDLES
K870866 · Pharmacia, Inc. · Jun 1987