Cleared Traditional

K033166 - KACEY INSULIN SYRINGE

K033166 is an FDA 510(k) clearance for KACEY INSULIN SYRINGE, manufactured by Kacey, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K033166 · Kacey, Inc. · General Hospital
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Dec 2003
Decision
73d
Days
Class 2
Risk

K033166 is an FDA 510(k) clearance for the KACEY INSULIN SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Kacey, Inc. (Rock Hill, US). The FDA issued a Cleared decision on December 12, 2003 after a review of 73 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 - K033166

510(k) Number K033166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date December 12, 2003
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
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 752
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K033166.
AUTODETECT SYRINGE
K041590 · Indigo Orb, Inc. · Jun 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · Vascular Solutions, Inc. · Feb 2004
ULTICARE DISPOSABLE SYRINGE 3 ML/CC
K033794 · Ultimed, Inc. · Dec 2003
NIPRO DISPOSABLE SYRINGES
K030683 · Nipro Medical Corp. · Oct 2003
AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE
K031394 · American Syringe Company · Jul 2003
SHANCHUAN SYRINGE
K021993 · Shangdong Zibo Shanchuan Medical Instruments Co. · Jun 2003
K033166 · KACEY INSULIN SYRINGE
Download PDF Kacey, Inc.