Cleared Traditional

K982966 - DISETRONIC PEN

K982966 is an FDA 510(k) clearance for DISETRONIC PEN, manufactured by Disetronic Medical Systems. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K982966 · Disetronic Medical Systems · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
55d
Days
Class 2
Risk

K982966 is an FDA 510(k) clearance for the DISETRONIC PEN. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Disetronic Medical Systems (Fort Myers, US). The FDA issued a Cleared decision on October 19, 1998 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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.

FDA 510(k) Submission Details - K982966

510(k) Number K982966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1998
Decision Date October 19, 1998
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 601
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K982966.
LITE-TOUCH SYRINGE
K983430 · Medicore, Inc. · Feb 1999
UNIFINE
K983994 · Owen Mumford USA, Inc. · Jan 1999
OWEN MUMFORD 3ML AUTOPEN
K983974 · Owen Mumford USA, Inc. · Dec 1998
PENETREASE
K980078 · P.T. Panca Pusaka Deli · Oct 1998
HUMAPEN AND HUMAPEN ERGO
K982842 · Eli Lilly and Co. · Sep 1998
LIGHT SABER ASPIRATION NEEDLE
K982018 · Minrad, Inc. · Aug 1998
K982966 · DISETRONIC PEN
Download PDF FDA Summary Disetronic Medical Sy…