Cleared Traditional

K082182 - AP 34 MULTI-THERAPY INFUSION PUMP

K082182 is an FDA 510(k) clearance for AP 34 MULTI-THERAPY INFUSION PUMP, manufactured by Q-Core, Ltd.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K082182 · Q-Core, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
14d
Days
Class 2
Risk

K082182 is an FDA 510(k) clearance for the AP 34 MULTI-THERAPY INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Q-Core, Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on August 15, 2008 after a review of 14 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 Q-Core, Ltd. devices

FDA 510(k) Submission Details - K082182

510(k) Number K082182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2008
Decision Date August 15, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 542
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K082182.
POWER INFUSER, MODEL M100B-3A
K090736 · ZOLL Medical Corporation · May 2009
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K081412 · Hospira, Inc. · Dec 2008
GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE
K083019 · Hospira, Inc. · Oct 2008
MEDRAD INTEGO PET INFUSION SYSTEM
K080297 · Medrad, Inc. · Jun 2008
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
K073051 · Medrad, Inc. · May 2008
LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP
K080743 · Smiths Medical MD, Inc. · Apr 2008