Cleared Special

THINSET 1.8 ML RESERVOIR, MODEL 326A (K041152) - FDA 510(k) Clearance

Also marketed or referenced as:
THINSET 3.0 ML RESERVOIR, MODEL 332A

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

K041152 · Applied Diabetes Research, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
21d
Days
Class 2
Risk

K041152 is an FDA 510(k) clearance for the THINSET 1.8 ML RESERVOIR, MODEL 326A. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Applied Diabetes Research, Inc. (Dana Point, US). The FDA issued a Cleared decision on May 24, 2004 after a review of 21 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 Applied Diabetes Research, Inc. devices

Submission Details

510(k) Number K041152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2004
Decision Date May 24, 2004
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 220
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K041152.
PUMP CONNECTIVITY INTERFACE
K040985 · Baxter Healthcare Corp · Nov 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · Abbott Laboratories · Jun 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · Baxter Healthcare Corp · Jun 2004
ABBOTT DATA PORT PC, MODEL 12181
K040114 · Abbott Laboratories · Jan 2004
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
K031185 · Abbott Laboratories · Apr 2003
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · Abbott Laboratories · Dec 2002