Cleared Traditional

K042122 - SMARTINFUSER PAINPUMP

K042122 is an FDA 510(k) clearance for SMARTINFUSER PAINPUMP, manufactured by Precise Medical Products. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K042122 · Precise Medical Products · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
47d
Days
Class 2
Risk

K042122 is an FDA 510(k) clearance for the SMARTINFUSER PAINPUMP. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Precise Medical Products (Shlomi, IL). The FDA issued a Cleared decision on September 22, 2004 after a review of 47 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.

FDA 510(k) Submission Details - K042122

510(k) Number K042122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2004
Decision Date September 22, 2004
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 K042122.
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117 · I-Flow Corp. · Sep 2005
SYMBIOS DISPOSABLE INFUSION PUMP KIT
K051474 · Symbios Medical Products, LLC · Jul 2005
MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
K050770 · Mckinley Medical, LLC · Apr 2005
MULTI-DRIP INFUSION CATHETER
K042246 · Advanced Infusion, Inc. · Aug 2004
AUTOFUSER AMBULATORY INFUSION PUMP
K041585 · Algos, LC · Aug 2004
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
K040337 · I-Flow Corp. · May 2004
K042122 · SMARTINFUSER PAINPUMP
Download PDF FDA Summary Precise Medical Produ…