Cleared Traditional

K973025 - FLUID CENTURION (4-100-00)

K973025 is an FDA 510(k) clearance for FLUID CENTURION (4-100-00), manufactured by Northgate Technologies, Inc.. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K973025 · Northgate Technologies, Inc. · General Hospital
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Nov 1997
Decision
98d
Days
Class 2
Risk

K973025 is an FDA 510(k) clearance for the FLUID CENTURION (4-100-00). Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on November 20, 1997 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2420 - 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 Northgate Technologies, Inc. devices

FDA 510(k) Submission Details - K973025

510(k) Number K973025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1997
Decision Date November 20, 1997
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLN Device Classification - Class 2, Special Controls

Product Code FLN Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2420
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 - FLN Monitor, Electric For Gravity Flow Infusion Systems

All 19
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K973025.
ISSYS DRUG FLOW MONITOR
K050783 · Integrated Sensing Systems, Inc. · Feb 2006
LEVELERT II FLUID LEVEL SENSOR
K060123 · Smith & Nephew, Inc. · Feb 2006
STRYKER L3 HYDROLERT
K022248 · Stryker Endoscopy · Aug 2002
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
K972084 · Alexander Mfg. Co. · Jul 1997
SMITH & NEPHEW DYONICS LEVELERT SYSTEM
K903193 · Smith & Nephew Dyonics, Inc. · Aug 1990
TRAVENOL FLO-GARD 500 IV MONITOR
K850710 · Travenol Laboratories, S.A. · Apr 1985