Cleared Traditional

K943664 - INTERMATE XLV ELASTOMERIC INFUSION SYSTEM

K943664 is the FDA 510(k) clearance for INTERMATE XLV ELASTOMERIC INFUSION SYSTEM by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code MEB) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K943664 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
98d
Days
Class 2
Risk

K943664 is an FDA 510(k) clearance for the INTERMATE XLV ELASTOMERIC INFUSION SYSTEM. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on November 3, 1994 after a review of 98 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 Corp devices

Submission Details

510(k) Number K943664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1994
Decision Date November 03, 1994
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEB Pump, Infusion, Elastomeric
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 - MEB Pump, Infusion, Elastomeric

All 32
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K943664.
TITAN 20 CC DRIVER
K954059 · I-Flow Corp. · Sep 1995
TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET
K953028 · I-Flow Corp. · Sep 1995
INFUSION PUMP
K941418 · I-Flow Corp. · Jul 1995
INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
K922382 · Baxter Healthcare Corp · Feb 1993
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD
K913658 · Imed Corp. · Mar 1992