Cleared Special

K070203 - INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024

K070203 is an FDA 510(k) clearance for INVIROSNAP SAFETY SYRINGE, manufactured by Inviro Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 91-day FDA review.

K070203 · Inviro Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
91d
Days
Class 2
Risk

K070203 is an FDA 510(k) clearance for the INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Inviro Medical Devices, Inc. (Duluth, US). The FDA issued a Cleared decision on April 23, 2007 after a review of 91 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K070203

510(k) Number K070203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2007
Decision Date April 23, 2007
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 K070203.
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
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CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
K072037 · Life-Shield Products, Inc. · Aug 2007
SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
K070117 · Dolomite Biotech Sdn Bhd · Aug 2007
SAF-T-SYRINGE- 0.5 AND 1ML/CC
K063340 · Safety Medical International, Incorporated · Mar 2007
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · Smiths Medical Asd, Inc. · Feb 2007
CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE
K062780 · Medical Device Manufacturer (Thailand) , Ltd. · Jan 2007
K070203 · INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
Download PDF FDA Summary Inviro Medical Device…