Cleared Traditional

K922214 - EMPTY VIAFLEX PLASTIC CONTAINER

K922214 is an FDA 510(k) clearance for EMPTY VIAFLEX PLASTIC 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 318-day FDA review.

K922214 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
318d
Days
Class 2
Risk

K922214 is an FDA 510(k) clearance for the EMPTY VIAFLEX PLASTIC CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on March 26, 1993 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K922214

510(k) Number K922214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1992
Decision Date March 26, 1993
Days to Decision 318 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
189d slower than avg
Panel avg: 129d · This submission: 318d
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 K922214.
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
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · Abbott Laboratories · Dec 1989
CHURCHILL PARENTERAL NUTRITION BAG - EVA
K870395 · Churchill Corp. · Oct 1987
INFUMIX MIXING CONTAINER
K870052 · Biodynamics Corp. · Feb 1987