Cleared Traditional

K960581 - SECURE EVA DUAL CHAMBER MIXING BAG

K960581 is an FDA 510(k) clearance for SECURE EVA DUAL CHAMBER MIXING BAG, manufactured by Secure Medical Products, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K960581 · Secure Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
78d
Days
Class 2
Risk

K960581 is an FDA 510(k) clearance for the SECURE EVA DUAL CHAMBER MIXING BAG. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Secure Medical Products, Inc. (Whitwater, US). The FDA issued a Cleared decision on April 30, 1996 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 880.5025 - 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 Secure Medical Products, Inc. devices

FDA 510(k) Submission Details - K960581

510(k) Number K960581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1996
Decision Date April 30, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

KPE Device Classification - Class 2, Special Controls

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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 - KPE Container, I.v.

All 54
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K960581.
CHARTERMED TPN-EVA BAGS
K973103 · Chartermed, Inc. · Nov 1997
VITALMIX PLUS EMPTY I.V. CONTAINER
K972464 · Pacific Device, Inc. · Nov 1997
INTRAVIA CONTAINER, EMPTY
K964853 · Baxter Healthcare Corp · Mar 1997
ALL-IN-ONE TWO CHAMBER CONTAINER
K945193 · Baxter Healthcare Corp · May 1995
UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET
K932477 · Baxter Healthcare Corp · Jun 1994
DISPOSABLE BAG DECANTER
K934179 · Byron Medical · May 1994