Cleared Traditional

K190663 - Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6

K190663 is an FDA 510(k) clearance for Epidural MiniFilter LUER 80369-7, manufactured by PAJUNK GmbH Medizintechnologie. The device is a Class 2 Anesthesiology device with product code BSN cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K190663 · PAJUNK GmbH Medizintechnologie · Anesthesiology device
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Jun 2019
Decision
94d
Days
Class 2
Risk

K190663 is an FDA 510(k) clearance for the Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6. Classified as Filter, Conduction, Anesthetic (product code BSN), Class II - Special Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on June 17, 2019 after a review of 94 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 PAJUNK GmbH Medizintechnologie devices

FDA 510(k) Submission Details - K190663

510(k) Number K190663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2019
Decision Date June 17, 2019
Days to Decision 94 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
46d faster than avg
Panel avg: 140d · This submission: 94d
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

All 7
Devices cleared under the same product code (BSN) and FDA review panel - the closest regulatory comparables to K190663.
VENTED MILLEX -GV, CATHIVEX -GV
K133004 · Merck Millipore , Ltd. · Mar 2014
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
MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)
K963717 · Millipore Corp. · Jun 1997
SYRINGEFILTER
K960928 · Arbor Technologies, Inc. · Apr 1997