Cleared Traditional

K023890 - PREPARE CARTRIDGE

K023890 is an FDA 510(k) clearance for PREPARE CARTRIDGE, manufactured by Appro Healthcare, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K023890 · Appro Healthcare, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
78d
Days
Class 2
Risk

K023890 is an FDA 510(k) clearance for the PREPARE CARTRIDGE. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Appro Healthcare, Inc. (Buffalo, US). The FDA issued a Cleared decision on February 7, 2003 after a review of 78 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 Appro Healthcare, Inc. devices

FDA 510(k) Submission Details - K023890

510(k) Number K023890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2002
Decision Date February 07, 2003
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
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 18
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K023890.
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