Cleared Traditional

K964858 - BEMIS TWO GALLON CHEMOTHERAPY CONTAINER

K964858 is an FDA 510(k) clearance for BEMIS TWO GALLON CHEMOTHERAPY CONTAINER, manufactured by Bemis Mfg. Co.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K964858 · Bemis Mfg. Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
69d
Days
Class 2
Risk

K964858 is an FDA 510(k) clearance for the BEMIS TWO GALLON CHEMOTHERAPY CONTAINER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Bemis Mfg. Co. (Sheboygan Falls, US). The FDA issued a Cleared decision on February 11, 1997 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 880.5570 - 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 Bemis Mfg. Co. devices

FDA 510(k) Submission Details - K964858

510(k) Number K964858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1996
Decision Date February 11, 1997
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 45
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K964858.
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K943659 · Sage Products, Inc. · Mar 1995
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K943660 · Sage Products, Inc. · Mar 1995