Cleared Traditional

K910323 - BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)

K910323 is an FDA 510(k) clearance for BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (F..., manufactured by Uab Research Foundation. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K910323 · Uab Research Foundation · General Hospital
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Oct 1991
Decision
252d
Days
Class 2
Risk

K910323 is an FDA 510(k) clearance for the BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000). Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Uab Research Foundation (Birmingham, US). The FDA issued a Cleared decision on October 3, 1991 after a review of 252 days - an extended review cycle.

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 Uab Research Foundation devices

FDA 510(k) Submission Details - K910323

510(k) Number K910323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1991
Decision Date October 03, 1991
Days to Decision 252 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 129d · This submission: 252d
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 21
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K910323.
STRYKER L3 HYDROLERT
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FLUID CENTURION (4-100-00)
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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
DROP RATE COUNTER #340
K831596 · Imed Corp. · Jul 1983