510(k) · Cleared
ClearedMicroflo-Safe Scalp Vein Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dks Loversan Industria Biomedica Spa · FPA Set, Administration, Intravascular
Cleared on Apr 15, 2005 as substantially equivalent to K031279 (Terumo Medical Products Hangzhou Co., Ltd., 2003) and 2 other predicates after a 134-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Apr 15, 2005
- Review
- 134 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K970259 (1997). 9 ancestors in all, the oldest K931367 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
- 3 generations backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 2 generations backK013164 Surshield Safety Winged Blood Collection SetTerumo Medical Corp. · 2001
- 1 generation backK031279 Surshield Safety Winged Blood Collection SetTerumo Medical Products Hangzhou Co., Ltd. · 2003
- This deviceK043328 Microflo-Safe Scalp Vein SetDks Loversan Industria Biomedica Spa · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −3 | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 1 |
| −2 | K013164 | Surshield Safety Winged Blood Collection Set | Terumo Medical Corp. | 2001 | — |
| −1 | K031279 | Surshield Safety Winged Blood Collection Set | Terumo Medical Products Hangzhou Co., Ltd. | 2003 | — |
| 0 (this device) | K043328 | Microflo-Safe Scalp Vein Set | Dks Loversan Industria Biomedica Spa | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K031279 | Surshield Safety Winged Blood Collection SetSummary page 1…tration, Intravascular Product Code: FPA Predicate Device: Surshield Safety Winged Blood Collection Set - Terumo Medical Products K031279 Unlok Plus Infusion Set - Myco Medical Supplies, Inc. K000592 VacuFlow + Safe Collection Set - MED-PRO Technologies… | 2003 |
| * | K000592 | Unolok Plus Infusion Set and Vaku-8 Plus Blood Collection SetSummary page 1…Predicate Device: Surshield Safety Winged Blood Collection Set - Terumo Medical Products K031279 Unlok Plus Infusion Set - Myco Medical Supplies, Inc. K000592 VacuFlow + Safe Collection Set - MED-PRO Technologies K000714 Intended Use: The MICROFLO-SAFE Scalp Vein Set is a win… | 2001 |
| * | K000714 | Vacuflow+Safe Blood Collection Set and Vacuflow+Safe with Holder Blood Collection SetSummary page 1…o Medical Products K031279 Unlok Plus Infusion Set - Myco Medical Supplies, Inc. K000592 VacuFlow + Safe Collection Set - MED-PRO Technologies K000714 Intended Use: The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood s… | 2000 |
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?
- The line of descent spans 8 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K031279.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for…
Read the full statement (106 words)
The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043328: Microflo-Safe Scalp Vein Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043328
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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