Cleared Traditional

FLUID MANAGEMENT SYSTEM (K852645) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852645 · Haemonetics Corp. · General Hospital
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Dec 1985
Decision
171d
Days
Class 2
Risk

K852645 is an FDA 510(k) clearance for the FLUID MANAGEMENT SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on December 9, 1985 after a review of 171 days - an extended review 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: 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 Haemonetics Corp. devices

Submission Details

510(k) Number K852645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1985
Decision Date December 09, 1985
Days to Decision 171 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
42d slower than avg
Panel avg: 129d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 236
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K852645.
FLO-GARD 6200 VOLUMETRIC INFUSION PUMP
K860162 · Travenol Laboratories, S.A. · Apr 1986
MODEL 900 INFUSION PUMP
K860229 · C.R. Bard, Inc. · Apr 1986
BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO
K853629 · C.R. Bard, Inc. · Jan 1986
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · Travenol Laboratories, S.A. · Dec 1985
TRAVENOL MULTIDAY INFUSOR 2C1080
K842905 · Travenol Laboratories, S.A. · Nov 1985
SYRINGE INFUSION PUMP - AS 20 SERIES
K852358 · Baxter Healthcare Corp · Jul 1985