510(k) · Cleared
ClearedFresenius Punctur-Guard Fistula Needle Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care · FIE Needle, Fistula
Cleared on Mar 20, 2003 as substantially equivalent to K003827 (Bio-Plexus, Inc., 2001) and 1 other predicate after a 178-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Mar 20, 2003
- Review
- 178 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003827 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK003827 Punctur-Guard Winged Set for Blood CollectionBio-Plexus, Inc. · 2001
- This deviceK023162 Fresenius Punctur-Guard Fistula Needle SetsFresenius Medical Care · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003827 | Punctur-Guard Winged Set for Blood Collection | Bio-Plexus, Inc. | 2001 | — |
| 0 (this device) | K023162 | Fresenius Punctur-Guard Fistula Needle Sets | Fresenius Medical Care | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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.
Planning a device in FIE? 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 FIE device
- #1 K253469 Ritus™ Safety Fistula Cannula with Anti-Reflux…score 13.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K003827 | Punctur-Guard Winged Set for Blood CollectionSummary page 1…. Predicate Device Name: The predicate devices for the Fresenius Punctur-Guard Fistula Needle Sets are Bio- Plexus Punctur-Guard Winged Set for Blood Collection (#K003827,1/8/2001) and the JMS AV Fistula Needle Set "Wing Eater" (#KO10406, 6/20/01). D. Indications for Use: The Fresenius PUNCT… | 2001 |
| * | K010406 | JMS a.V. Fistula Needle Set Wing Eater, Model 14G-18G | 2001 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FIE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIE
91in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIE
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIE
33in 2025
MAUDE reports naming product code FIE, 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 | 3 | 90 | 0 | 13 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 27 |
| 2010 | 3 | 29 | 0 | 17 |
| 2011 | 3 | 91 | 0 | 2 |
| 2012 | 1 | — | 3 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 2 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 1 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 21 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 58 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Fresenius PUNCTUR-GUARD@Fistula Needle Set is indicated for use as a non-implantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit. The set includes a needlestick prevention device using PUNC7UR-GUARD@technology. The features of this device may aid in the prevention of needlestick injury. This device is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023162: Fresenius Punctur-Guard Fistula Needle Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023162
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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