Cleared Traditional

K922382 - INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE

K922382 is an FDA 510(k) clearance for INTERMATE LV ELASTOMERIC INFUSION DEVICE, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K922382 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
261d
Days
Class 2
Risk

K922382 is an FDA 510(k) clearance for the INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE. 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 February 5, 1993 after a review of 261 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.

FDA 510(k) Submission Details - K922382

510(k) Number K922382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date February 05, 1993
Days to Decision 261 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
132d slower than avg
Panel avg: 129d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEB Device Classification - Class 2, Special Controls

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 87
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K922382.
DIB INFUSOR
K941766 · Novacon Corp. · Aug 1994
MID-500
K940117 · Block Medical, Inc. · Jun 1994
DIB INFUSOR
K930404 · Novacon Corp. · Feb 1994
PRIME CADI-120
K914148 · Prime Medical Products, Inc. · Oct 1992
GENESIS(TM) INFUSION SYSTEM
K911636 · Norman'S · Jul 1992
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD
K913658 · Imed Corp. · Mar 1992
K922382 · INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
Download PDF FDA Summary Baxter Healthcare Corp