Cleared Traditional

K983454 - PAIN CARE 2000

K983454 is an FDA 510(k) clearance for PAIN CARE 2000, manufactured by Breg, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K983454 · Breg, Inc. · General Hospital
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Dec 1998
Decision
77d
Days
Class 2
Risk

K983454 is an FDA 510(k) clearance for the PAIN CARE 2000. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 77 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 Breg, Inc. devices

FDA 510(k) Submission Details - K983454

510(k) Number K983454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1998
Decision Date December 16, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
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 59
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K983454.
AUTODOSE INFUSION SYSTEM
K990889 · Tandem Medical, Inc. · Jun 1999
NERVE BLOCK INFUSION KIT
K984502 · I-Flow Corp. · Mar 1999
PREPARE HOME INFUSION PUMP
K983634 · Medical Infusion Technologies, Inc. · Feb 1999
PAINBUSTER INFUSION KIT
K982946 · I-Flow Corp. · Nov 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