Cleared Traditional

K040036 - INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905

K040036 is an FDA 510(k) clearance for INVIRO SNAP SAFETY INSULIN SYRINGE, manufactured by Inviro Medical. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K040036 · Inviro Medical · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
69d
Days
Class 2
Risk

K040036 is an FDA 510(k) clearance for the INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905. 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 March 18, 2004 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040036

510(k) Number K040036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2004
Decision Date March 18, 2004
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K040036.
PERFECT SAFETY SYRINGE
K030604 · Perfect Medical Industry Co., Ltd. · Apr 2004
OTTER SAFETY SYRINGE
K040545 · Otter (China) Technology Co., Ltd. · Apr 2004
YUE PFONG SAFETY SYRINGE (3ML)
K040105 · Yue Pfong International Industrial Co., Ltd. · Apr 2004
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
K040036 · INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905
Download PDF FDA Summary Inviro Medical