Cleared Traditional

TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET (K001461) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Biometrix , Ltd. devices

Submission Details

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
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.

Device Classification

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 30
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K001461.
DUAL CHAMBER TPN CONTAINER
K073538 · B.Braun Medical, Inc. · Mar 2008
EVA TPN CONTAINER
K041415 · B.Braun Medical, Inc. · Aug 2004
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · Baxter Healthcare Corp · Mar 2002
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
K983294 · Baxter Healthcare Corp · Nov 1998
INTRAVIA CONTAINER, EMPTY
K964853 · Baxter Healthcare Corp · Mar 1997
ALL-IN-ONE TWO CHAMBER CONTAINER
K945193 · Baxter Healthcare Corp · May 1995