Cleared Traditional

K972678 - MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS

K972678 is an FDA 510(k) clearance for MILLENNIUM CRT INFUSION PUMP AND MILLEN..., manufactured by Mcgaw, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K972678 · Mcgaw, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
83d
Days
Class 2
Risk

K972678 is an FDA 510(k) clearance for the MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION .... Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Mcgaw, Inc. (Irvine, US). The FDA issued a Cleared decision on October 7, 1997 after a review of 83 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mcgaw, Inc. devices

FDA 510(k) Submission Details - K972678

510(k) Number K972678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1997
Decision Date October 07, 1997
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
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 542
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K972678.
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
FLUID MANAGEMENT SYSTEM
K972284 · Belmont Instrument Corp. · Nov 1997
BIG BAG 3000 PRESSURE INFUSOR
K973133 · Byron Medical · Sep 1997
PULSE*SPRAY INJECTOR
K963574 · AngioDynamics, Inc. · Jul 1997
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K965230 · Abbott Mfg., Inc. · Jul 1997