Cleared Traditional

K083451 - PORTEX EPIDURAL FILTER

K083451 is an FDA 510(k) clearance for PORTEX EPIDURAL FILTER, manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 Anesthesiology device with product code BSN cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K083451 · Smiths Medical Asd, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
103d
Days
Class 2
Risk

K083451 is an FDA 510(k) clearance for the PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS. Classified as Filter, Conduction, Anesthetic (product code BSN), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on March 4, 2009 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5130 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Smiths Medical Asd, Inc. devices

FDA 510(k) Submission Details - K083451

510(k) Number K083451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2008
Decision Date March 04, 2009
Days to Decision 103 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 140d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSN Device Classification - Class 2, Special Controls

Product Code BSN Filter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5130
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSN Filter, Conduction, Anesthetic

Devices cleared under the same product code (BSN) and FDA review panel - the closest regulatory comparables to K083451.
Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
K190663 · PAJUNK GmbH Medizintechnologie · Jun 2019
MILLEX VV, GV, AND HV SYRINGE FILTER UNITS
K023892 · Millipore Corp. · Jan 2003
MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
K013988 · Millipore Corp. · Apr 2002
MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)
K963717 · Millipore Corp. · Jun 1997
FILTER TUBE
K780519 · Jelco Laboratories · May 1978