Cleared Traditional

K926123 - DUAL CHAMBER MIXING BAG

K926123 is an FDA 510(k) clearance for DUAL CHAMBER MIXING BAG, manufactured by Secure Medical, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K926123 · Secure Medical, Inc. · General Hospital
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Sep 1993
Decision
273d
Days
Class 2
Risk

K926123 is an FDA 510(k) clearance for the DUAL CHAMBER MIXING BAG. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Secure Medical, Inc. (Mundelein, US). The FDA issued a Cleared decision on September 3, 1993 after a review of 273 days - an extended review 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: 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 Secure Medical, Inc. devices

FDA 510(k) Submission Details - K926123

510(k) Number K926123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1992
Decision Date September 03, 1993
Days to Decision 273 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
144d slower than avg
Panel avg: 129d · This submission: 273d
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 60
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K926123.
PHARMAFEED
K932649 · Plasco, Inc. · Nov 1993
EVA EMPTY MIXING CONTAINER
K932640 · Douglas Medical Products Corp. · Nov 1993
EMPTY MIXING CONTAINER
K932641 · Douglas Medical Products Corp. · Nov 1993
EMPTY VIAFLEX PLASTIC CONTAINER
K922214 · Baxter Healthcare Corp · Mar 1993
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · Abbott Laboratories · Dec 1989
CHURCHILL PARENTERAL NUTRITION BAG - EVA
K870395 · Churchill Corp. · Oct 1987