Cleared Special

DISENTRONIC PENFINE INJECTION PEN NEEDLE (K994197) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K994197 · Disetronic Medical Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
16d
Days
Class 2
Risk

K994197 is an FDA 510(k) clearance for the DISENTRONIC PENFINE INJECTION PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Disetronic Medical Systems (Fort Myers, US). The FDA issued a Cleared decision on December 29, 1999 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Disetronic Medical Systems devices

Submission Details

510(k) Number K994197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1999
Decision Date December 29, 1999
Days to Decision 16 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K994197.
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
LUER ACCESS UNIVERSAL VIAL ADAPTER
K000657 · Baxter Healthcare Corp · Mar 2000
BECTON DICKINSON BLUNT PLASTIC CANNULA
K974363 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
BECTON DICKINSON TWINPAK
K974006 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1998
BECTON DICKINSON BLUNT PLASTIC CANNULA
K964654 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1997