510(k) · Cleared
Recalled · Class II · 2015Nipro Safetouch Tulip Safety Fistula Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corporation · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Sep 7, 2007 as substantially equivalent to K932074 (Medisystems Corp., 1994) and 1 other predicate after a 136-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it. It has been recalled once.
- Decided
- Sep 7, 2007
- Review
- 136 days
- Class
- Class II
- Product code
- MPB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932074 (1994). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK932074 Medisystems Apheresis Needle with GuardMedisystems Corp. · 1994
- This deviceK071145 Nipro Safetouch Tulip Safety Fistula NeedleNipro Medical Corporation · 2007
- Descendant · cites it directly · 1 of its ownK163025 DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK213015 DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK171505 Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and…Dimesol, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2017 · cites it directly1descendant
- K213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd. · 2022 · 2 generations on0descendants
- K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV…Dimesol, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932074 | Medisystems Apheresis Needle with Guard | Medisystems Corp. | 1994 | — |
| 0 (this device) | K071145 | Nipro Safetouch Tulip Safety Fistula Needle | Nipro Medical Corporation | 2007 | — |
| +1 | K163025 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017 | — |
| +2 | K213015 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2022 | — |
| +1 | K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol… | Dimesol, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 MPB? 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 MPB device
- #1 K250836 14F Duo-Flow® Side X Side Double Lumen Catheterscore 10.1 · 2 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 |
|---|---|---|---|
| * | K932074 | Medisystems Apheresis Needle with GuardSummary page 1…Product Code: FIE 807. 92 (a) (3) Legally marketed substantial equivalent device: Medisystems MasterguardT M AVF Needle (K932074) Nipro AVF Needle (K955182) 807.92(a)(4) Description of device: The NIPRO SafeT… | 1994 |
| * | K955182 | Nipro Arterial Venous Fistula NeedleSummary page 1…92 (a) (3) Legally marketed substantial equivalent device: Medisystems MasterguardT M AVF Needle (K932074) Nipro AVF Needle (K955182) 807.92(a)(4) Description of device: The NIPRO SafeTouch TULIPTM Safety Fistula Needle is a st… | 1996 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Aug 13, 2015 | Class II | Z-0161-2016 | Mixed-up of materials/components | Some 1 1/4" needles were packaged and labeled in the 1" blister package. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MPB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPB
205in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPB
4so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · MPB
187in 2025
MAUDE reports naming product code MPB, 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 | 136 | 1 | 41 |
| 2008 | 0 | — | 0 | 147 |
| 2009 | 1 | — | 0 | 166 |
| 2010 | 1 | — | 0 | 60 |
| 2011 | 2 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 78 |
| 2013 | 1 | — | 0 | 124 |
| 2014 | 0 | — | 0 | 82 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 70 |
| 2017 | 2 | — | 2 | 86 |
| 2018 | 0 | — | 0 | 120 |
| 2019 | 0 | — | 0 | 119 |
| 2020 | 3 | 205 | 0 | 179 |
| 2021 | 0 | — | 0 | 192 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 203 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 0 | — | 4 (3) | — |
What is it indicated for?
The NIPRO SafeTouch TULIP TM Safety Fistula Needle is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. Secondly, it is designed with an anti-stick needle protector requiring physical action by the clinician to aid in the prevention of accidental needlesticks. 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/K071145 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071145: Nipro Safetouch Tulip Safety Fistula Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071145
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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