Cleared Traditional

K982170 - FLUIDSENSE FLUID DELIVERY SYSTEM

K982170 is an FDA 510(k) clearance for FLUIDSENSE FLUID DELIVERY SYSTEM, manufactured by Fluidsense Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K982170 · Fluidsense Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
164d
Days
Class 2
Risk

K982170 is an FDA 510(k) clearance for the FLUIDSENSE FLUID DELIVERY SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Fluidsense Corp. (Newburyport, US). The FDA issued a Cleared decision on November 30, 1998 after a review of 164 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 Fluidsense Corp. devices

FDA 510(k) Submission Details - K982170

510(k) Number K982170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1998
Decision Date November 30, 1998
Days to Decision 164 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 129d · This submission: 164d
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 542
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K982170.
VARIABLE PRESSURE SYRINGE PUMP
K974332 · Alaris Medical Systems, Inc. · Dec 1998
MELODIE INFUSION PUMP
K980378 · Compagnie DE Developpement Aguettant · Dec 1998
CUE AMBULATORY VOLUMETRIC INFUSION PUMP
K981816 · Becton Dickinson Curlin, LLC · Dec 1998
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K983975 · Belmont Instrument Corp. · Nov 1998
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K982838 · Sims Deltec, Inc. · Nov 1998