Cleared Traditional

K013782 - DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE

K013782 is an FDA 510(k) clearance for DISETRONIC PENFINE INSULIN INJECTION PE..., manufactured by Disetronic Medical Systems. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K013782 · Disetronic Medical Systems · General Hospital
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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

FDA 510(k) Submission Details - K013782

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
Combination Product No
PCCP Authorized No
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.

FMI Device Classification - Class 2, Special Controls

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 321
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K013782.
BD ULTRA-FINE III PEN NEEDLE
K024109 · Becton, Dickinson & CO · Dec 2002
SURE-LOK
K021315 · Vital Signs, Inc. · Aug 2002
NIPRO HYPODERMIC NEEDLE
K013293 · Nipro Medical Corp. · Dec 2001
JMS APHERESIS NEEDLE SET ACCORDION TYPE
K002394 · Jms Co., Ltd. · Sep 2001
BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
K011984 · Becton, Dickinson & CO · Aug 2001
TERUMO 30 GAUGE HYPODERMIC NEEDLE
K012646 · Terumo Medical Corp. · Aug 2001