Cleared Traditional

DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE (K013782) - FDA 510(k) Clearance

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

K013782 · Disetronic Medical Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
6d
Days
Class 2
Risk

K013782 is an FDA 510(k) clearance for the DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Disetronic Medical Systems (St. Paul, US). The FDA issued a Cleared decision on November 20, 2001 after a review of 6 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Disetronic Medical Systems devices

Submission Details

510(k) Number K013782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2001
Decision Date November 20, 2001
Days to Decision 6 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
123d faster than avg
Panel avg: 129d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 183
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K013782.
MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE
K043397 · Becton, Dickinson & CO · Dec 2004
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
K031200 · Becton, Dickinson & CO · Jun 2003
BD ULTRA-FINE III PEN NEEDLE
K024109 · Becton, Dickinson & CO · Dec 2002
BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
K011984 · Becton, Dickinson & CO · Aug 2001
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 2001
B-D ULTRA-FINE III PEN NEEDLE
K002938 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 2000