Cleared Traditional

K832254 - BAXA ADDISEAL

K832254 is an FDA 510(k) clearance for BAXA ADDISEAL, manufactured by Baxa Corp., Sub. of Cook Group, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K832254 · Baxa Corp., Sub. of Cook Group, Inc. · General Hospital
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Jul 1983
Decision
15d
Days
Class 2
Risk

K832254 is an FDA 510(k) clearance for the BAXA ADDISEAL. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Baxa Corp., Sub. of Cook Group, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 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 Baxa Corp., Sub. of Cook Group, Inc. devices

FDA 510(k) Submission Details - K832254

510(k) Number K832254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1983
Decision Date July 26, 1983
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 K832254.
NUTRIMIX EMPTY CONTAINER
K844077 · Abbott Laboratories · Feb 1985
EMPTY SOLUTION TRANSFER CONTAINER
K842170 · The Healthcare Group Laboratories, Inc. · Oct 1984
EMPTY SOLUTION TRANSFER CONTAINER 1000
K843523 · Polymer Technology Corp. · Oct 1984
CAT 3040
K830193 · Burron Medical Products, Inc. · Mar 1983
DELMED IV CONTAINER
K830450 · Delmed, Inc. · Mar 1983
SOLUTION TRANSFER CONTAINER
K830299 · The Healthcare Group Laboratories, Inc. · Feb 1983