Cleared Traditional

K071088 - LIFE LATCH SHARPS & BIOHAZARD CONTAINER

K071088 is an FDA 510(k) clearance for LIFE LATCH SHARPS & BIOHAZARD CONTAINER, manufactured by M&M Industries, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K071088 · M&M Industries, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2007
Decision
78d
Days
Class 2
Risk

K071088 is an FDA 510(k) clearance for the LIFE LATCH SHARPS & BIOHAZARD CONTAINER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by M&M Industries, Inc. (Potomac, US). The FDA issued a Cleared decision on July 5, 2007 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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.

View all M&M Industries, Inc. devices

FDA 510(k) Submission Details - K071088

510(k) Number K071088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2007
Decision Date July 05, 2007
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 362
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K071088.
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ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
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K071785 · Smiths Medical Asd, Inc. · Aug 2007
BD HYPOINT NEEDLE
K070440 · Becton, Dickinson & CO · Mar 2007
EZ-MIO STERNAL
K063567 · Vidacare Corporation · Jan 2007
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110
K063450 · Smiths Medical Asd, Inc. · Jan 2007