Cleared Traditional

K873729 - RATE-MATE NITROGLYCERIN I.V. ADMINISTRA...

K873729 is an FDA 510(k) clearance for RATE-MATE NITROGLYCERIN I.V. ADMINISTRA..., 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 105-day FDA review.

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

FDA 510(k) Submission Details - K873729

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
Combination Product No
PCCP Authorized No
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.

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 539
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K873729.
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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
PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET
K873885 · Pharmacia Deltec, Inc. · Nov 1987