Cleared Traditional

K003915 - ACCUFUSER

Also marketed or referenced as:
ACCUFUSER PLUS

K003915 is an FDA 510(k) clearance for ACCUFUSER, manufactured by Help Technologies. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K003915 · Help Technologies · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
58d
Days
Class 2
Risk

K003915 is an FDA 510(k) clearance for the ACCUFUSER. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Help Technologies (Dana Point, US). The FDA issued a Cleared decision on February 15, 2001 after a review of 58 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 Help Technologies devices

FDA 510(k) Submission Details - K003915

510(k) Number K003915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2000
Decision Date February 15, 2001
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
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 55
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K003915.
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
K020660 · I-Flow Corp. · Mar 2002
PAIN CARE 3200
K013928 · Breg, Inc. · Dec 2001
MULTIRATE INFUSOR SV
K011317 · Baxter Healthcare Corp · Jun 2001
PAIN CARE 3000
K002073 · Breg, Inc. · Sep 2000
PAIN CARE 2000L
K002321 · Breg, Inc. · Aug 2000
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
K993832 · Tandem Medical, Inc. · Feb 2000