Cleared Traditional

K964853 - INTRAVIA CONTAINER, EMPTY

K964853 is an FDA 510(k) clearance for INTRAVIA 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 118-day FDA review.

K964853 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
118d
Days
Class 2
Risk

K964853 is an FDA 510(k) clearance for the INTRAVIA CONTAINER, EMPTY. 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 31, 1997 after a review of 118 days - within the typical 510(k) review window.

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 - K964853

510(k) Number K964853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1996
Decision Date March 31, 1997
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
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 K964853.
STERI-TAMP
K974180 · Pharmacy, Inc. · Feb 1998
CHARTERMED TPN-EVA BAGS
K973103 · Chartermed, Inc. · Nov 1997
VITALMIX PLUS EMPTY I.V. CONTAINER
K972464 · Pacific Device, Inc. · Nov 1997
SECURE EVA DUAL CHAMBER MIXING BAG
K960581 · Secure Medical Products, Inc. · Apr 1996
ALL-IN-ONE TWO CHAMBER CONTAINER
K945193 · Baxter Healthcare Corp · May 1995
UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET
K932477 · Baxter Healthcare Corp · Jun 1994