510(k) · Cleared
ClearedPortex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · BSN Filter, Conduction, Anesthetic
Cleared on Mar 4, 2009 after a 103-day review. The FDA summary names its predicate without a number. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Mar 4, 2009
- Review
- 103 days
- Class
- Class II
- Product code
- BSN
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- This deviceK083451 Portex Epidural Filter, Model 100/386/010, Various Standard and…Smiths Medical Asd, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK110053 Correctinject Safety System, Catheter Connector, Filter, Infusion…Smiths Medical Asd, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK162219 CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK143581 Arrow Epidural Catheter KitTeleflexmedical, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK211649 PCEA Syringe SetBaxter Healthcare Corporation · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K162219 CADD® Infusion Disposables Portfolio with NRFit™…2 generations on · 2017
Most influential descendants
Showing 5 of 9 · See all- K110053Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitSmiths Medical Asd, Inc. · 2012 · cites it directly5descendants
- K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd. · 2017 · cites it directly1descendant
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · 2 generations on1descendant
- K143581Arrow Epidural Catheter KitTeleflexmedical, Inc. · 2015 · cites it directly1descendant
- K211649PCEA Syringe SetBaxter Healthcare Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083451 | Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays | Smiths Medical Asd, Inc. | 2009 | — |
| +1 | K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor… | Smiths Medical Asd, Inc. | 2012 | — |
| +1 | K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +… | Intervene Group, Ltd. | 2017 | — |
| +2 | K162219 | CADD® Infusion Disposables Portfolio with NRFit™ connectors | Smiths Medical Asd, Inc. | 2017 | Class I |
| +1 | K143581 | Arrow Epidural Catheter Kit | Teleflexmedical, Inc. | 2015 | — |
| +3 | K211649 | PCEA Syringe Set | Baxter Healthcare Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | B. Braun Medical Inc. 0.22 Micron Flat Epidural Filter Named without a submission number |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit | 2012 | 5 |
| K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6… | 2017 | 1 |
| K143581 | Arrow Epidural Catheter Kit | 2015 | 1 |
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K110053 (Smiths Medical Asd, Inc., 2012) has gone furthest, with 5 descendants of its own.
How does its category compare?
All BSN devicesBSN Filter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BSN
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · BSN
Too few BSN 510(k)s in any year since 2007 to give a median.
Recalls per year · BSN
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BSN
6in 2025
MAUDE reports naming product code BSN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 88 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083451: Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083451
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026