Cleared Traditional

K963717 - MILLEX - MP FILTER UNIT (SLMPO25SS/SLMP...

K963717 is an FDA 510(k) clearance for MILLEX - MP FILTER UNIT (SLMPO25SS/SLMP..., manufactured by Millipore Corp.. The device is a Class 2 Anesthesiology device with product code BSN cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K963717 · Millipore Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
267d
Days
Class 2
Risk

K963717 is an FDA 510(k) clearance for the MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS). Classified as Filter, Conduction, Anesthetic (product code BSN), Class II - Special Controls.

Submitted by Millipore Corp. (Bedford, US). The FDA issued a Cleared decision on June 10, 1997 after a review of 267 days - an extended review cycle.

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 Millipore Corp. devices

FDA 510(k) Submission Details - K963717

510(k) Number K963717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date June 10, 1997
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 140d · This submission: 267d
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 K963717.
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
K083451 · Smiths Medical Asd, Inc. · Mar 2009
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
FILTER TUBE
K780519 · Jelco Laboratories · May 1978