Cleared Traditional

K090096 - ALL-IN-ONE CONTAINER

K090096 is the FDA 510(k) clearance for ALL-IN-ONE CONTAINER by Baxter Healthcare Corporation. It is a Class 2 General Hospital device (product code KPE) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K090096 · Baxter Healthcare Corporation · General Hospital
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Jan 2009
Decision
15d
Days
Class 2
Risk

K090096 is an FDA 510(k) clearance for the ALL-IN-ONE CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Mcgaw Park, US). The FDA issued a Cleared decision on January 30, 2009 after a review of 15 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 Baxter Healthcare Corporation devices

Submission Details

510(k) Number K090096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2009
Decision Date January 30, 2009
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPE Container, I.v.

All 34
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K090096.
Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP
K181393 · Valmed S.R.L. · Feb 2019
STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
K132276 · Hospira, Inc. · Nov 2013
ADDITIVE CAP
K111217 · Baxter Healthcare Corp · Jun 2011
DUAL CHAMBER TPN CONTAINER
K073538 · B.Braun Medical, Inc. · Mar 2008
EVA TPN CONTAINER
K041415 · B.Braun Medical, Inc. · Aug 2004
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · Baxter Healthcare Corp · Mar 2002

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.