Cleared Traditional

MICROJET CRONO PCA (K013822) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013822 · Cane S.R.L. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
173d
Days
Class 2
Risk

K013822 is an FDA 510(k) clearance for the MICROJET CRONO PCA. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by Cane S.R.L. (Deer Field, US). The FDA issued a Cleared decision on May 8, 2002 after a review of 173 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 Cane S.R.L. devices

Submission Details

510(k) Number K013822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2001
Decision Date May 08, 2002
Days to Decision 173 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
44d slower than avg
Panel avg: 129d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEA Pump, Infusion, Pca
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 - MEA Pump, Infusion, Pca

All 30
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K013822.
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
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BARD PCA II PUMP WITH PROGRAM CARTRIDGES
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