Cleared Traditional

K925056 - SAFESHARPE (TM) DISPOSAL SYSTEM

K925056 is an FDA 510(k) clearance for SAFESHARPE (TM) DISPOSAL SYSTEM, manufactured by Life Medical Technologies, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 927-day FDA review.

K925056 · Life Medical Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
927d
Days
Class 2
Risk

K925056 is an FDA 510(k) clearance for the SAFESHARPE (TM) DISPOSAL SYSTEM. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Life Medical Technologies, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 21, 1995 after a review of 927 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Life Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K925056

510(k) Number K925056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1992
Decision Date April 21, 1995
Days to Decision 927 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
798d slower than avg
Panel avg: 129d · This submission: 927d
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 508
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K925056.
ISOLYSER SHARPS MANAGEMENT SYSTEM SMS
K943626 · Thantex Specialties, Inc. · Jun 1995
MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER
K951515 · Sherwood Medical Co. · May 1995
B-D ULTRA-FINE II PEN NEEDLE
K950466 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1995
SECURE SAFETY INSERT
K945825 · Syncor Intl. Corp. · Apr 1995
MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
K945809 · Sherwood Medical Co. · Mar 1995
PISTON SYRINGES
K944757 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995