Cleared Traditional

K002705 - EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400

K002705 is an FDA 510(k) clearance for EXACTA-MIX 2400 COMPOUNDING SYSTEM, manufactured by Baxa Corp.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K002705 · Baxa Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
210d
Days
Class 2
Risk

K002705 is an FDA 510(k) clearance for the EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Baxa Corp. (Englewood, US). The FDA issued a Cleared decision on March 28, 2001 after a review of 210 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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.

FDA 510(k) Submission Details - K002705

510(k) Number K002705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2000
Decision Date March 28, 2001
Days to Decision 210 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
81d slower than avg
Panel avg: 129d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 189
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K002705.
SINGLE DOSE DISPENSING PIN, MODEL 2201
K013087 · Alaris Medical Systems, Inc. · Nov 2001
INTER-VIAL
K010703 · Duoject Medical Systems, Inc. · Jun 2001
RECONSTITUTION KIT & VIAL CONNECTOR
K010623 · Bioject, Inc. · Apr 2001
CHEMO-AIDE DISPENSING PIN
K003730 · Baxter Healthcare Corp · Dec 2000
NEEDLELESS TRANSFER DEVICE
K001831 · Medimop Medical Projects, Ltd. · Jul 2000
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
K001368 · Carmel Pharma Ab. · May 2000
K002705 · EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
Download PDF FDA Summary Baxa Corp.