Cleared Traditional

K852645 - FLUID MANAGEMENT SYSTEM

K852645 is an FDA 510(k) clearance for FLUID MANAGEMENT SYSTEM, manufactured by Haemonetics Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 171-day FDA review.

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

FDA 510(k) Submission Details - K852645

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
Combination Product No
PCCP Authorized No
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.

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 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K852645.
ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY
K852168 · Y · Mar 1986
BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO
K853629 · C.R. Bard, Inc. · Jan 1986
MP0400 ADULT, PERISTALIC INFUSION PUMP
K853814 · Medex, Inc. · Jan 1986
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · Travenol Laboratories, S.A. · Dec 1985
NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8
K853134 · Erika, Inc. · Nov 1985
TRAVENOL MULTIDAY INFUSOR 2C1080
K842905 · Travenol Laboratories, S.A. · Nov 1985