Cleared Traditional

INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES (K081436) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081436 · Inviro Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
154d
Days
Class 2
Risk

K081436 is an FDA 510(k) clearance for the INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES. 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 October 22, 2008 after a review of 154 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Inviro Medical Devices, Inc. devices

Submission Details

510(k) Number K081436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2008
Decision Date October 22, 2008
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 226
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K081436.
MERIT MEDICAL 20 ML SYRINGE
K111091 · Merit Medical Systems, Inc. · Jun 2011
COAXIAL APPLICATOR SYSTEM
K091722 · Biomet, Inc. · Mar 2010
BD FLU+ SYRINGE
K091377 · Becton, Dickinson & CO · Jul 2009
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · Biomet, Inc. · Dec 2007
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459 · B.Braun Medical, Inc. · Aug 2007
TERUMO 31G THINPRO INSULIN SYRINGE
K071630 · Terumo Medical Corp. · Jul 2007