510(k) · Cleared
Recalled · Class III · 2014Modification to: Nipro Safe Touch Safety Fistula Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corp. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Nov 14, 2003 as substantially equivalent to K002813 (Nipro Medical Corp., 2000) after a 67-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 14, 2003
- Review
- 67 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002813 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002813 Nipro Safetouch Safety Fistula NeedleNipro Medical Corp. · 2000 · Recalled
- This deviceK032777 Modification to: Nipro Safe Touch Safety Fistula NeedleNipro Medical Corp. · 2003
- Descendant · cites it directly · 0 of its ownK093985 Nipro Safetouch Locktail Safety Fistula NeedleNipro Medical Corp. · 2010
- Descendant · cites it directly · 0 of its ownK063721 Nipro Safetouch II GammaNipro Medical Corp. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002813 | Nipro Safetouch Safety Fistula Needle | Nipro Medical Corp. | 2000 | 1 |
| 0 (this device) | K032777 | Modification to: Nipro Safe Touch Safety Fistula Needle | Nipro Medical Corp. | 2003 | — |
| +1 | K093985 | Nipro Safetouch Locktail Safety Fistula Needle | Nipro Medical Corp. | 2010 | — |
| +1 | K063721 | Nipro Safetouch II Gamma | Nipro Medical Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K002813 | Nipro Safetouch Safety Fistula Needle | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2014 | Class III | Z-0599-2016 | Process control | Device has the potential to have torn wings. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K093985 (Nipro Medical Corp., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The Nipro SafeTouch Safety Fistula Needles is intended for use as a blood access device for blood purification and for other treatments requiring extracorporeal circuit. The Nipro SafeTouch Safety Fistula Needle aids in the prevention of accidental needle stick injuries. The compatibility of available configurations is the responsibility of the physician in charge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032777 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032777: Modification to: Nipro Safe Touch 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/K032777
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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