Cleared Traditional

K982946 - PAINBUSTER INFUSION KIT

K982946 is an FDA 510(k) clearance for PAINBUSTER INFUSION KIT, manufactured by I-Flow Corp.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K982946 · I-Flow Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
89d
Days
Class 2
Risk

K982946 is an FDA 510(k) clearance for the PAINBUSTER INFUSION KIT. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by I-Flow Corp. (Lake Forest, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 89 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 I-Flow Corp. devices

FDA 510(k) Submission Details - K982946

510(k) Number K982946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1998
Decision Date November 18, 1998
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 77
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K982946.
NERVE BLOCK INFUSION KIT
K984502 · I-Flow Corp. · Mar 1999
PREPARE HOME INFUSION PUMP
K983634 · Medical Infusion Technologies, Inc. · Feb 1999
PAIN CARE 2000
K983454 · Breg, Inc. · Dec 1998
OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP
K982256 · Mckinley, Inc. · Sep 1998
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
PAINBUSTER INFUSION SYSTEM
K980558 · I-Flow Corp. · May 1998