Cleared Traditional

K972284 - FLUID MANAGEMENT SYSTEM

K972284 is an FDA 510(k) clearance for FLUID MANAGEMENT SYSTEM, manufactured by Belmont Instrument Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K972284 · Belmont Instrument Corp. · General Hospital
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Nov 1997
Decision
147d
Days
Class 2
Risk

K972284 is an FDA 510(k) clearance for the FLUID MANAGEMENT SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Belmont Instrument Corp. (Billerica, US). The FDA issued a Cleared decision on November 13, 1997 after a review of 147 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 Belmont Instrument Corp. devices

FDA 510(k) Submission Details - K972284

510(k) Number K972284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 19, 1997
Decision Date November 13, 1997
Days to Decision 147 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
18d slower than avg
Panel avg: 129d · This submission: 147d
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 541
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K972284.
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM
K973917 · Sims Deltec, Inc. · Jan 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
K973851 · Alexander Mfg. Co. · Jan 1998
IDA-4 AND IPT-MC
K973609 · Bio-Tek Instruments, Inc. · Dec 1997
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS
K972678 · Mcgaw, Inc. · Oct 1997
BIG BAG 3000 PRESSURE INFUSOR
K973133 · Byron Medical · Sep 1997
PULSE*SPRAY INJECTOR
K963574 · AngioDynamics, Inc. · Jul 1997