510(k) · Cleared
ClearedFilter Needle for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · FPB Filter, Infusion Line
Cleared on May 10, 2024 as substantially equivalent to K801343 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1980) after a 224-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- May 10, 2024
- Review
- 224 days
- Class
- Class II
- Product code
- FPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K801343 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK801343 B-D Filter NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1980
- This deviceK233277 Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801343 | B-D Filter Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980 | — |
| 0 (this device) | K233277 | Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024 | — |
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 K261403 Lipipor NLF1A Infusion Filter, Lipipor NLF2A &…score 11.9 · 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 |
|---|---|---|---|
| * | K801343 | B-D Filter NeedleSummary page 5…LE Common name: Infusion Line Filter Classification: Class II, 21 CFR 880.5440 Product Code: FPB Premarket Notification: K801343 Manufacturer: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC… | 1980 |
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.
- 1 other device also cites its predicate K801343.
How does its category compare?
All FPB devicesFPB Filter, Infusion Line: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
This product is intended for the aspiration, filtration and preparation ofmedical fluid, not including injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233277: Filter Needle for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233277
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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