Cleared Traditional

K120209 - PATIENT CONTROLLED ANALGESIA (PCA) BUTT...

K120209 is an FDA 510(k) clearance for PATIENT CONTROLLED ANALGESIA (PCA) BUTT..., manufactured by American I.V. Products, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K120209 · American I.V. Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
79d
Days
Class 2
Risk

K120209 is an FDA 510(k) clearance for the PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by American I.V. Products, Inc. (Harmans, US). The FDA issued a Cleared decision on April 12, 2012 after a review of 79 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 American I.V. Products, Inc. devices

FDA 510(k) Submission Details - K120209

510(k) Number K120209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2012
Decision Date April 12, 2012
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, 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 - MRZ Accessories, Pump, Infusion

All 21
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K120209.
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