Cleared Traditional

K965248 - BEMIS TWO GALLON SHARPS CONTAINER

K965248 is an FDA 510(k) clearance for BEMIS TWO GALLON SHARPS CONTAINER, manufactured by Bemis Mfg. Co.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K965248 · Bemis Mfg. Co. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
72d
Days
Class 2
Risk

K965248 is an FDA 510(k) clearance for the BEMIS TWO GALLON SHARPS CONTAINER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bemis Mfg. Co. (Sheboygan Falls, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 72 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.

FDA 510(k) Submission Details - K965248

510(k) Number K965248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1996
Decision Date February 14, 1997
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
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 621
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K965248.
BECTON DICKINSON BLUNT PLASTIC CANNULA
K964654 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1997
B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
K970737 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1997
LIFESHIELD BLUNT CANNULA
K963351 · Abbott Laboratories · Feb 1997
SHARPS CONTAINER MODEL# SC001
K963830 · Image Medical, Inc. · Feb 1997
MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
K962001 · Manan Medical Products, Inc. · Jan 1997
SERAGARD VASCULAR ACCESS DEVICE
K963595 · Cutting Edge Technologies, Inc. · Jan 1997
K965248 · BEMIS TWO GALLON SHARPS CONTAINER
Download PDF FDA Summary Bemis Mfg. Co.