Cleared Traditional

K945193 - ALL-IN-ONE TWO CHAMBER CONTAINER

K945193 is an FDA 510(k) clearance for ALL-IN-ONE TWO CHAMBER CONTAINER, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K945193 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
200d
Days
Class 2
Risk

K945193 is an FDA 510(k) clearance for the ALL-IN-ONE TWO CHAMBER CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Jayuya, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 200 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K945193

510(k) Number K945193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1994
Decision Date May 12, 1995
Days to Decision 200 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
71d slower than avg
Panel avg: 129d · This submission: 200d
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 56
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K945193.
VITALMIX PLUS EMPTY I.V. CONTAINER
K972464 · Pacific Device, Inc. · Nov 1997
INTRAVIA CONTAINER, EMPTY
K964853 · Baxter Healthcare Corp · Mar 1997
SECURE EVA DUAL CHAMBER MIXING BAG
K960581 · Secure Medical Products, Inc. · Apr 1996
UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET
K932477 · Baxter Healthcare Corp · Jun 1994
DISPOSABLE BAG DECANTER
K934179 · Byron Medical · May 1994
PHARMAFEED
K932649 · Plasco, Inc. · Nov 1993