510(k) · Cleared
ClearedLipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Life Sciences Solutions USA, LLC · FPB Filter, Infusion Line
Cleared on Aug 31, 2026 as substantially equivalent to K905794 (Pall Biomedical Products Co., 1991) after a 124-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Aug 31, 2026
- Review
- 124 days
- Class
- Class II
- Product code
- FPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905794 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK905794 Pall 3N1 FilterPall Biomedical Products Co. · 1991 · Recalled
- This deviceK261403 Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion…Global Life Sciences Solutions USA, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905794 | Pall 3N1 Filter | Pall Biomedical Products Co. | 1991 | 1 |
| 0 (this device) | K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters… | Global Life Sciences Solutions USA, LLC | 2026 | — |
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 FPB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPB device
- #1 K233277 Filter Needle for Single Usescore 7.3 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K905794 | Pall 3N1 FilterSummary page 5…avascular administration set Regulatory Class: Class II FDA Product Code: FPB Predicate Device: Pall Corporation 3N1 Filter (K905794) Intended Use / Indications for Use The Lipipor NLF1A, NLF2A, NLF2NTA, and TNA2A Infusion Filters are intended for use within t… | 1991 |
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 a recall.
How does its category compare?
All FPB devicesFPB Filter, Infusion Line: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FPB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FPB
Too few FPB 510(k)s in any year since 2007 to give a median.
Recalls per year · FPB
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPB
33in 2025
MAUDE reports naming product code FPB, 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 | 14 |
| 2008 | 0 | — | 0 | 44 |
| 2009 | 0 | — | 0 | 33 |
| 2010 | 0 | — | 0 | 32 |
| 2011 | 1 | — | 1 | 20 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 67 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 0 | — | 0 | 95 |
| 2017 | 0 | — | 0 | 53 |
| 2018 | 0 | — | 0 | 35 |
| 2019 | 0 | — | 0 | 31 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 160 |
| 2022 | 0 | — | 0 | 36 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 1 | — | 0 | 47 |
| 2025 | 0 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Lipipor NLF1A, NLF2A, NLF2NTA, and TNA2A Infusion Filters are intended for use within the healthcare environment such as hospitals, healthcare facilities or clinical settings for infusion line filtering.
The Lipipor Infusion Filters are indicated for the removal of inadvertent particulate debris and microbial contaminants larger than 1.2 pm and entrained air which may be found in intravenous solutions, parenteral nutrition admixtures, and injectable lipid emulsions. They are also indicated for the removal of inadvertent enlarged lipid droplets from parenteral nutrition admixtures and injectable lipid emulsions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261403: Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261403
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026