Cleared Traditional

K972464 - VITALMIX PLUS EMPTY I.V. CONTAINER

K972464 is an FDA 510(k) clearance for VITALMIX PLUS EMPTY I.V. CONTAINER, manufactured by Pacific Device, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K972464 · Pacific Device, Inc. · General Hospital
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Nov 1997
Decision
127d
Days
Class 2
Risk

K972464 is an FDA 510(k) clearance for the VITALMIX PLUS EMPTY I.V. CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Pacific Device, Inc. (San Diego, US). The FDA issued a Cleared decision on November 5, 1997 after a review of 127 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 Pacific Device, Inc. devices

FDA 510(k) Submission Details - K972464

510(k) Number K972464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1997
Decision Date November 05, 1997
Days to Decision 127 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
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 53
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K972464.
MPS RESERVOIR BAG
K982048 · Medical Product Specialists · Jul 1998
STERI-TAMP
K974180 · Pharmacy, Inc. · Feb 1998
CHARTERMED TPN-EVA BAGS
K973103 · Chartermed, Inc. · Nov 1997
INTRAVIA CONTAINER, EMPTY
K964853 · Baxter Healthcare Corp · Mar 1997
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