Cleared Special

K101359 - INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)

K101359 is an FDA 510(k) clearance for INVIROSTRIPE LUER LOCK SYRINGES (1, manufactured by Inviro Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 98-day FDA review.

K101359 · Inviro Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
98d
Days
Class 2
Risk

K101359 is an FDA 510(k) clearance for the INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Inviro Medical Devices, Inc. (Lawrenceville, US). The FDA issued a Cleared decision on August 20, 2010 after a review of 98 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 - K101359

510(k) Number K101359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2010
Decision Date August 20, 2010
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

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 634
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K101359.
IMC PISTON SYRINGES
K102969 · International Medsurg Connection · Dec 2010
HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)
K101547 · Henke-Sass, Wolf GmbH · Nov 2010
EASY TOUCH
K102178 · Mhc Medical Products · Sep 2010
HUMAPEN LUXURA HD
K100988 · Eli Lilly and Company · Aug 2010
MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
K100665 · Needle Tech Products, Inc. · Jun 2010
GRAFT DELIVERY SYSTEM MODEL SA-6115
K100754 · Micromedics, Inc. · Jun 2010
K101359 · INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)
Download PDF FDA Summary Inviro Medical Device…