Cleared Special

K032780 - INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC

K032780 is an FDA 510(k) clearance for INVIRO SNAP SAFETY SYRINGE, manufactured by Inviro Medical. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 16-day FDA review.

K032780 · Inviro Medical · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
16d
Days
Class 2
Risk

K032780 is an FDA 510(k) clearance for the INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Inviro Medical (Laguna Niguel, US). The FDA issued a Cleared decision on September 24, 2003 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 880.5860 - 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 - K032780

510(k) Number K032780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2003
Decision Date September 24, 2003
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K032780.
10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
K034031 · M.K. Meditech Co. , Ltd. · Jan 2004
BETEC RETRACTABLE SAFETY SYRINGE (5ML)
K031909 · Betec Medical Science Co., Ltd. · Oct 2003
U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE
K032247 · U.S. Technologies, Inc. · Sep 2003
SAFEPRO PLUS SAFETY SYRINGE
K031830 · Formosa Medical Devices, Inc. · Aug 2003
SEZ SAFETY SYRINGE
K031163 · Sez Corporation · Jul 2003
SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
K031065 · Syringex Medical, Inc. · Jun 2003
K032780 · INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC
Download PDF FDA Summary Inviro Medical