Cleared Special

FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 (K003582) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003582 · Fluidsense Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
15d
Days
Class 2
Risk

K003582 is an FDA 510(k) clearance for the FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Fluidsense Corp. (Newburyport, US). The FDA issued a Cleared decision on December 5, 2000 after a review of 15 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fluidsense Corp. devices

Submission Details

510(k) Number K003582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2000
Decision Date December 05, 2000
Days to Decision 15 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 221
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K003582.
ABBOTT ACCLAIM ENCORE, MODEL 12237
K011096 · Abbott Laboratories · May 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · Abbott Laboratories · Apr 2001
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
K003616 · Baxter Healthcare Corp · Dec 2000
6060 MULTI-THERAPY PUMP, MODEL 2M9832
K002679 · Baxter Healthcare Corp · Sep 2000
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
K002380 · Baxter Healthcare Corp · Sep 2000
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
K002211 · Baxter Healthcare Corp · Jul 2000