Cleared Traditional

K001461 - TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET

K001461 is an FDA 510(k) clearance for TPN NUTRITION BAG (EVA), manufactured by Biometrix , Ltd.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K001461 · Biometrix , Ltd. · General Hospital
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Sep 2000
Decision
124d
Days
Class 2
Risk

K001461 is an FDA 510(k) clearance for the TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Biometrix , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on September 11, 2000 after a review of 124 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.

FDA 510(k) Submission Details - K001461

510(k) Number K001461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2000
Decision Date September 11, 2000
Days to Decision 124 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
5d faster than avg
Panel avg: 129d · This submission: 124d
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 67
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K001461.
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
K031419 · Laboratorios Grifols, S.A. · Nov 2003
EVA EMPTY SOLUTION CONTAINER
K030888 · Metrix Co. · Apr 2003
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · Baxter Healthcare Corp · Mar 2002
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
K001287 · Sorenson Medical, Inc. · Jun 2000
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
K983294 · Baxter Healthcare Corp · Nov 1998
MPS RESERVOIR BAG
K982048 · Medical Product Specialists · Jul 1998