510(k) · Cleared
ClearedNipro Safetouch PSV Scalp Vein Set with Safety Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corporation · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Feb 14, 2014 as substantially equivalent to K011297 (Nipro Medical Corp., 2001) after a 28-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Feb 14, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011297 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011297 Nipro Safetouch Scalp Vein and Blood Collection SetNipro Medical Corp. · 2001 · Recalled
- This deviceK140136 Nipro Safetouch PSV Scalp Vein Set with Safety DeviceNipro Medical Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011297 | Nipro Safetouch Scalp Vein and Blood Collection Set | Nipro Medical Corp. | 2001 | 1 |
| 0 (this device) | K140136 | Nipro Safetouch PSV Scalp Vein Set with Safety Device | Nipro Medical Corporation | 2014 | — |
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 |
|---|---|---|---|
| * | K011297 | Nipro Safetouch Scalp Vein and Blood Collection SetSummary page 1…r: 21 CFR 880.5200 Panel: 80 Product Code: FOZ 807.92(a)(3) Legally marketed substantial equivalent device: Nipro SafeTouch Scalp Vein Set - K011297 807.92(a)(4) Description of device: The SafeTouch PSV Scalp Vein Set with Safety Device isa safety intravascular… | 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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K011297.
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. 2014, this device’s year, is highlighted.
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 PSV Scalp Vein Set with Safety Device is intended to be used for insertion into a patient's vascular system (for single use) as an indwelling device to administer fluids intravenously or to sample blood. Secondly, it is designed with an active sharp feature that requires physical action by the clinician to prevent needlestick incidents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140136 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140136: Nipro Safetouch PSV Scalp Vein Set with Safety Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140136
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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