Cleared Traditional

K013822 - MICROJET CRONO PCA

K013822 is an FDA 510(k) clearance for MICROJET CRONO PCA, manufactured by Cane S.R.L.. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 173-day FDA review.

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

FDA 510(k) Submission Details - K013822

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.

MEA Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K013822.
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · Baxter Healthcare Corp · Aug 2003
STRYKER PAINPUMP2
K030661 · Stryker Instruments · May 2003
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · Abbott Laboratories · Aug 2002
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · Baxter Healthcare Corp · Sep 2000
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839 · Sims Deltec, Inc. · Nov 1998
MODEL 6100 AMBULATORY INFUSION SYSTEM
K943310 · Pharmacia Deltec, Inc. · Feb 1995