Cleared Traditional

K955514 - SHARPS SAFE 1.5 & SHARPS SAFE 2.0

K955514 is an FDA 510(k) clearance for SHARPS SAFE 1.5 & SHARPS SAFE 2.0, manufactured by Dura-Vac Products. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K955514 · Dura-Vac Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
241d
Days
Class 2
Risk

K955514 is an FDA 510(k) clearance for the SHARPS SAFE 1.5 & SHARPS SAFE 2.0. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Dura-Vac Products (Ventura, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 241 days - an extended review 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: 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 Dura-Vac Products devices

FDA 510(k) Submission Details - K955514

510(k) Number K955514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1995
Decision Date August 01, 1996
Days to Decision 241 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
112d slower than avg
Panel avg: 129d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMK Device Classification - Class 2, Special Controls

Product Code MMK Container, Sharps
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 - MMK Container, Sharps

All 70
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K955514.
SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
K980490 · Sage Products, Inc. · Feb 1998
POINT OF USE II SHARPS-A-GATOR
K964387 · Graphic Controls Corp. · Mar 1997
BEMIS TWO GALLON CHEMOTHERAPY CONTAINER
K964858 · Bemis Mfg. Co. · Feb 1997
BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)
K960525 · Bemis Mfg. Co. · Mar 1996
CHEMOTHERAPY WASTE DISPOSAL CONTAINERS
K943658 · Sage Products, Inc. · Mar 1995
ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS
K943659 · Sage Products, Inc. · Mar 1995