Cleared Traditional

K965222 - MICROJECT MODEL PCA-1

K965222 is an FDA 510(k) clearance for MICROJECT MODEL PCA-1, manufactured by Microject, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K965222 · Microject, Inc. · General Hospital
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Jun 1997
Decision
170d
Days
Class 2
Risk

K965222 is an FDA 510(k) clearance for the MICROJECT MODEL PCA-1. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Microject, Inc. (West Valley City, US). The FDA issued a Cleared decision on June 19, 1997 after a review of 170 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Microject, Inc. devices

FDA 510(k) Submission Details - K965222

510(k) Number K965222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1996
Decision Date June 19, 1997
Days to Decision 170 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 129d · This submission: 170d
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 41
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K965222.
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