Cleared Traditional

SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY (K982102) - FDA 510(k) Clearance

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

K982102 · Baxter Healthcare Corp · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 1998
Decision
81d
Days
Class 2
Risk

K982102 is an FDA 510(k) clearance for the SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 M.... 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 September 4, 1998 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K982102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1998
Decision Date September 04, 1998
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
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 K982102.
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
K021274 · Baxter Healthcare Corp · May 2002
MULTIRATE INFUSOR SV
K011317 · Baxter Healthcare Corp · Jun 2001
DISPOSABLE INFUSION PUMP KIT
K993972 · Biomet, Inc. · Feb 2000
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
INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
K922382 · Baxter Healthcare Corp · Feb 1993