510(k) · Cleared
Recalled · Class II · 2013Nipro Safetouch Scalp Vein and Blood Collection Set
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 Jun 20, 2001 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled once.
- Decided
- Jun 20, 2001
- Review
- 51 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK011297 Nipro Safetouch Scalp Vein and Blood Collection SetNipro Medical Corp. · 2001
- Descendant · cites it directly · 7 of its ownK080235 Safety Infusion SetGreiner Bio-One Vacuette North America · 2008
- Descendant · 2 generations on · 6 of its ownK121908 Safety Infusion SetGreiner Bio-One North America, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK173757 VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK170276 Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc. · 2017
- Descendant · 4 generations on · 1 of its ownK214075 Safety Blood Collection / Infusion Set (with/without needle holder)…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K080235Safety Infusion SetGreiner Bio-One Vacuette North America · 2008 · cites it directly7descendants
- K121908Safety Infusion SetGreiner Bio-One North America, Inc. · 2012 · 2 generations on6descendants
- K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 2018 · 3 generations on2descendants
- K170276Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc. · 2017 · 3 generations on2descendants
- K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011297 | Nipro Safetouch Scalp Vein and Blood Collection Set | Nipro Medical Corp. | 2001 | — |
| +1 | K080235 | Safety Infusion Set | Greiner Bio-One Vacuette North America | 2008 | — |
| +2 | K121908 | Safety Infusion Set | Greiner Bio-One North America, Inc. | 2012 | — |
| +3 | K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | Greiner Bio-One Na, Inc. | 2018 | — |
| +3 | K170276 | Safety Blood Collection Device for Single Use | Gemtier Medical (Shanghai), Inc. | 2017 | — |
| +4 | K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood… | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 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 |
|---|---|---|---|---|
| May 4, 2013 | Class II | Z-1834-2014 | Component design/selection | There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080235 (Greiner Bio-One Vacuette North America, 2008) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K011297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011297: Nipro Safetouch Scalp Vein and Blood Collection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011297
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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