Cleared Traditional

K080904 - FEEL-FINE INSULIN PEN NEEDLE

K080904 is an FDA 510(k) clearance for FEEL-FINE INSULIN PEN NEEDLE, manufactured by Feel Tech. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K080904 · Feel Tech · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
64d
Days
Class 2
Risk

K080904 is an FDA 510(k) clearance for the FEEL-FINE INSULIN PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Feel Tech (Deer Field, US). The FDA issued a Cleared decision on June 4, 2008 after a review of 64 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.

FDA 510(k) Submission Details - K080904

510(k) Number K080904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2008
Decision Date June 04, 2008
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 632
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K080904.
MEDIGARD BLOOD COLLECTION DEVICE
K082511 · Medigard Limited · Jan 2009
K-PACK II NEEDLE - 29G THIN WALL
K082820 · Terumo Europe N.V. · Oct 2008
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
K072602 · Medpro Safety Products, Inc. · Jun 2008
SAFETY INFUSION SET
K080235 · Greiner Bio-One Vacuette North America · Apr 2008
FAST1 INTRAOSSEOUS INFUSION SYSTEM
K080865 · Pyng Medical Corp. · Apr 2008
MODEL TW SB, SCALP VEIN SET
K073705 · Shandong Qiaopai Group Co., Ltd. · Mar 2008
K080904 · FEEL-FINE INSULIN PEN NEEDLE
Download PDF FDA Summary Feel Tech