Cleared Traditional

K860969 - FLUID MANAGEMENT SYSTEM (MODIFIED)

K860969 is an FDA 510(k) clearance for FLUID MANAGEMENT SYSTEM (MODIFIED), 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 56-day FDA review.

K860969 · Haemonetics Corp. · General Hospital
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May 1986
Decision
56d
Days
Class 2
Risk

K860969 is an FDA 510(k) clearance for the FLUID MANAGEMENT SYSTEM (MODIFIED). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on May 6, 1986 after a review of 56 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 Haemonetics Corp. devices

FDA 510(k) Submission Details - K860969

510(k) Number K860969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1986
Decision Date May 06, 1986
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 K860969.
SOF SET, MODELS 111 AND 112
K861436 · Pacesetter Systems · Jun 1986
SOF SET, MODELS 113 AND 114
K860857 · Pacesetter Systems · May 1986
BECTON DICKINSON PCAINFUSER
K861007 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1986
IV7200 AND IV7400 INFUSION PUMP
K860694 · Valleylab, Inc. · Apr 1986
FLO-GARD 6200 VOLUMETRIC INFUSION PUMP
K860162 · Travenol Laboratories, S.A. · Apr 1986
MODEL 900 INFUSION PUMP
K860229 · C.R. Bard, Inc. · Apr 1986