Cleared Traditional

K955622 - AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM

K955622 is an FDA 510(k) clearance for AUTOMIX PLUS, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 512-day FDA review.

K955622 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
512d
Days
Class 2
Risk

K955622 is an FDA 510(k) clearance for the AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 6, 1997 after a review of 512 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K955622

510(k) Number K955622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date May 06, 1997
Days to Decision 512 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
383d slower than avg
Panel avg: 129d · This submission: 512d
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 134
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K955622.
AUTOMIX 3+3/AS COMPOUNDER SYSTEM
K961008 · Baxter Healthcare Corp · Oct 1997
MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW
K972117 · Medical Specialty Innovations, Inc. (Msi) · Aug 1997
BAG DECANTER
K972134 · Remington Medical, Inc. · Aug 1997
SAFE-CONNECT VIAL DISPENSING SPIKE
K970789 · Faulding Medical Device Co. · May 1997
CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)
K964989 · Critical Device Corp. · Apr 1997
COMBIPROT EMERGENCY ENFUSION DEVICE
K970359 · B.Braun Medical, Inc. · Mar 1997