510(k) · Cleared
Recalled · 2002Nipro Safetouch Safety Fistula Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corp. · FIE Needle, Fistula
Cleared on Nov 21, 2000 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 21, 2000
- Review
- 74 days
- Class
- Class II
- Product code
- FIE
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK002813 Nipro Safetouch Safety Fistula NeedleNipro Medical Corp. · 2000
- Descendant · cites it directly · 2 of its ownK032777 Modification to: Nipro Safe Touch Safety Fistula NeedleNipro Medical Corp. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK093985 Nipro Safetouch Locktail Safety Fistula NeedleNipro Medical Corp. · 2010
- Descendant · 2 generations on · 0 of its ownK063721 Nipro Safetouch II GammaNipro Medical Corp. · 2007
Most influential descendants
Showing 3 of 3 · See all- K032777Modification to: Nipro Safe Touch Safety Fistula NeedleNipro Medical Corp. · 2003 · cites it directly2descendants
- K093985Nipro Safetouch Locktail Safety Fistula NeedleNipro Medical Corp. · 2010 · 2 generations on0descendants
- K063721Nipro Safetouch II GammaNipro Medical Corp. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002813 | Nipro Safetouch Safety Fistula Needle | Nipro Medical Corp. | 2000 | — |
| +1 | K032777 | Modification to: Nipro Safe Touch Safety Fistula Needle | Nipro Medical Corp. | 2003 | 1 |
| +2 | K093985 | Nipro Safetouch Locktail Safety Fistula Needle | Nipro Medical Corp. | 2010 | — |
| +2 | K063721 | Nipro Safetouch II Gamma | Nipro Medical Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032777 | Modification to: Nipro Safe Touch Safety Fistula Needle | 2003 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2002 | Not classified | Z-0408-03 | Other | Air or fluid leakage at the hub/needle junction. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032777 (Nipro Medical Corp., 2003) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K002813 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002813: Nipro Safetouch Safety Fistula Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002813
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026