# K083451: Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Mar 4, 2009 after 103 days
- Product code: BSN (Filter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) B. Braun Medical Inc. 0.22 Micron Flat Epidural Filter: named in the summary without a submission number

## Most influential descendants
- K110053: Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit (2012), 5 descendants of its own
- K170900: DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories (2017), 1 descendant of its own
- K162219: CADD® Infusion Disposables Portfolio with NRFit™ connectors (2017), 1 descendant of its own
- K143581: Arrow Epidural Catheter Kit (2015), 1 descendant of its own
- K211649: PCEA Syringe Set (2021), 0 descendants of its own

## Indications for use
An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.

Source page: https://510kreport.com/device/K083451
Methodology: https://510kreport.com/methodology