Cleared Traditional

MICROJET MODEL # CD4 AND CD4/20 (K013776) - FDA 510(k) Clearance

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

K013776 · Cane S.R.I. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
164d
Days
Class 2
Risk

K013776 is an FDA 510(k) clearance for the MICROJET MODEL # CD4 AND CD4/20. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cane S.R.I. (Deer Field, US). The FDA issued a Cleared decision on April 26, 2002 after a review of 164 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.I. devices

Submission Details

510(k) Number K013776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date April 26, 2002
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN 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 - FRN Pump, Infusion

All 220
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K013776.
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
K031185 · Abbott Laboratories · Apr 2003
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · Abbott Laboratories · Dec 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K021350 · Abbott Laboratories · May 2002
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · Smith & Nephew, Inc. · Apr 2002
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · Abbott Laboratories · Jun 2001
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · Baxter Healthcare Corp · May 2001