510(k) · Cleared

Cleared

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

K190663510(k) TraditionalCleared Jun 17, 201994-day reviewClass II21 CFR 868.5130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

PAJUNK GmbH Medizintechnologie · BSN Filter, Conduction, Anesthetic

Cleared on Jun 17, 2019 as substantially equivalent to K083451 (Smiths Medical Asd, Inc., 2009) after a 94-day review. Its family tree reaches back 1 generation to 2009.

Decided: Jun 17, 2019
Review: 94 days
Class: Class II
Product code: BSN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K083451 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK083451 Portex Epidural Filter, Model 100/386/010, Various Standard and…Smiths Medical Asd, Inc. · 2009
This deviceK190663 Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6PAJUNK GmbH Medizintechnologie · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K083451	Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays	Smiths Medical Asd, Inc.	2009	—
0 (this device)	K190663	Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6	PAJUNK GmbH Medizintechnologie	2019	—

FIG. 1 — Lineage of K190663, 2009–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in BSN? 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

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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	Applicant	Decided	Recalls
*	K083451	Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays Summary page 5 …latory Class: II Panel: Anesthesiology Predicate Device K083451, Portex® Epidural Filter PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for 2 types of Anaesthesia Conduction Filter…	Smiths Medical Asd, Inc.	2009	—

Also cleared against K083451: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
3 other devices also cite its predicate K083451.

How does its category compare?

All BSN devices

BSN Filter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · BSN

1in 2019

2007high 1 (2009) · low 0 (2007)2026

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

2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · BSN

6in 2025

2007high 88 (2012) · low 0 (2007)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?

The Pajunk Epidural MiniFilter NRFit (ISO80369-6) and Epidural MiniFilter LUER (ISO80369-7) is an anesthesia conduction filter. An anesthesia conduction filter is a microporous filter used while administering to a patient injection of local anaesthetics to minimize particulate (foreign material) contamination of the injected fluid. The anaesthesia conduction filter is intended for use for patients that weigh 10kg and above.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190663 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190663: Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190663

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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