Cleared Traditional

K872764 - IVAC NITROGLYCERIN & LIPID ADMIN. SET M...

K872764 is the FDA 510(k) clearance for IVAC NITROGLYCERIN & LIPID ADMIN. SET M... by Y. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K872764 · Y · General Hospital
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Nov 1987
Decision
113d
Days
Class 2
Risk

K872764 is an FDA 510(k) clearance for the IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on November 3, 1987 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Y devices

Submission Details

510(k) Number K872764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1987
Decision Date November 03, 1987
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 447
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K872764.
CORMED III AMBULATORY INFUSION PUMP
K873847 · C.R. Bard, Inc. · Dec 1987
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+
K873776 · Y · Dec 1987
VALLEYLAB MODEL IV7200 INFUSION PUMP
K873161 · Valleylab, Inc. · Nov 1987
IMED(R) 980C VOLUMETRIC INFUSION PUMP
K870656 · Imed Corp. · Oct 1987
NUTRIPUMP
K872741 · I M, Inc. · Oct 1987
ULTRASONIC AIR-IN-LINE DETECTOR (AILD)
K872952 · Imed Corp. · Oct 1987