Cleared Traditional

K001461 - TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET (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
4d faster than avg
Panel avg: 128d · 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 116
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