Cleared Traditional

K871084 - NITROGLYCERINE PUMP SET

K871084 is an FDA 510(k) clearance for NITROGLYCERINE PUMP SET, manufactured by Churchill Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K871084 · Churchill Corp. · General Hospital
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Jul 1987
Decision
120d
Days
Class 2
Risk

K871084 is an FDA 510(k) clearance for the NITROGLYCERINE PUMP SET. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Churchill Corp. (Langhorne, US). The FDA issued a Cleared decision on July 16, 1987 after a review of 120 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 Churchill Corp. devices

FDA 510(k) Submission Details - K871084

510(k) Number K871084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date July 16, 1987
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 601
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K871084.
RATE INFUSER SYSTEM
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K871728 · Abbott Laboratories · Jul 1987
INFUSION PUMP ENCLOSURE
K872821 · Pharmacia Deltec, Inc. · Jul 1987
IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP
K870991 · Imed Corp. · Jun 1987
IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP
K870992 · Imed Corp. · Jun 1987
AMBULATORY INFUSION PUMP DRUG RESERVOIR
K870524 · Med Fusion Systems, Inc. · May 1987