Cleared Traditional

INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE (K922382) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922382 · Baxter Healthcare Corp · General Hospital
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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.

View all Baxter Healthcare Corp devices

Submission Details

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.

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 12
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K922382.
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
K982102 · Baxter Healthcare Corp · Sep 1998
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
K971168 · Baxter Healthcare Corp · Jul 1997
INTERMATE XLV ELASTOMERIC INFUSION SYSTEM
K943664 · Baxter Healthcare Corp · Nov 1994