Cleared Special

K033373 - MONOJECT INSULIN SYRINGE

K033373 is an FDA 510(k) clearance for MONOJECT INSULIN SYRINGE, manufactured by Tyco Healthcare. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 22-day FDA review.

K033373 · Tyco Healthcare · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
22d
Days
Class 2
Risk

K033373 is an FDA 510(k) clearance for the MONOJECT INSULIN SYRINGE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on November 13, 2003 after a review of 22 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.

FDA 510(k) Submission Details - K033373

510(k) Number K033373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2003
Decision Date November 13, 2003
Days to Decision 22 days
Submission Type Special
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
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 695
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K033373.
SECUMAX BLOOD COLLECTION SYSTEM
K032141 · Tiger Meditech Incorporated · Jan 2004
AMERSHAM HEALTH NEEDLE-GUARD
K033409 · Gettig Pharmaceutical Instrument Co. · Jan 2004
VACUETTE QUICKSHIELD SAFETY TUBE HOLDER
K033478 · Greiner Bio-One Vacuette North America · Dec 2003
TERUMO SURGUARD 2 SAFETY NEEDLE
K031453 · Terumo Medical Corp. · Jul 2003
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
K031200 · Becton, Dickinson & CO · Jun 2003
CORD STICK MULTIPLE DRAW SYSTEM
K031058 · Cord Stick Corp. · Jun 2003
K033373 · MONOJECT INSULIN SYRINGE
Download PDF FDA Summary Tyco Healthcare