Cleared Traditional

K993524 - ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS

K993524 is an FDA 510(k) clearance for ADVANTIS ASC INFUSION PUMP AND ADMINIST..., manufactured by Alaris Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K993524 · Alaris Medical Systems, Inc. · General Hospital
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Aug 2000
Decision
288d
Days
Class 2
Risk

K993524 is an FDA 510(k) clearance for the ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Alaris Medical Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on August 1, 2000 after a review of 288 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 Alaris Medical Systems, Inc. devices

FDA 510(k) Submission Details - K993524

510(k) Number K993524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1999
Decision Date August 01, 2000
Days to Decision 288 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
159d slower than avg
Panel avg: 129d · This submission: 288d
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 523
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K993524.
INFUSOMAT P
K003029 · B.Braun Medical, Inc. · 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
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · Abbott Laboratories · Jul 2000
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
K000842 · Sims Deltec, Inc. · Jun 2000