Cleared Traditional

K081436 - INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES

K081436 is an FDA 510(k) clearance for INVIROSTRIPE 3ML, manufactured by Inviro Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K081436 · Inviro Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K081436

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
Combination Product No
PCCP Authorized No
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.

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 K081436.
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K081436 · INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES
Download PDF FDA Summary Inviro Medical Device…