Cleared Traditional

K133801 - BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

K133801 is an FDA 510(k) clearance for BAXTER SIGMA SPECTRUM INFUSION PUMP WIT..., manufactured by Baxter Healthcare Corporation. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K133801 · Baxter Healthcare Corporation · General Hospital
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Optimized for regulatory review, auditing and printing
May 2014
Decision
145d
Days
Class 2
Risk

K133801 is an FDA 510(k) clearance for the BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on May 7, 2014 after a review of 145 days - within the typical 510(k) review window.

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 Baxter Healthcare Corporation devices

FDA 510(k) Submission Details - K133801

510(k) Number K133801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2013
Decision Date May 07, 2014
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
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 591
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K133801.
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THE BELMONT RAPID INFUSER
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K141102 · Hospira, Inc. · Jul 2014
SAPPHIRE INFUSION PUMP
K123049 · Q Core Medical , Ltd. · Oct 2013
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K123822 · Hk Surgical, Inc. · Sep 2013
Z-800 INFUSION SYSTEM
K130690 · Zyno Medical, LLC · Jun 2013