510(k) · Cleared
ClearedPrimero Safe Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
South53, LLC · DYB Introducer, Catheter
Cleared on Sep 29, 2025 as substantially equivalent to K111606 (Terumo Medical Corp., 2011) after a 56-day review. Its family tree reaches back 6 generations to 1995. 1 of the 12 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 29, 2025
- Review
- 56 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954234 (1995). 11 ancestors in all, the oldest K810675 (1981). No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 5 generations backK033681 GlidesheathTerumo Corp. · 2003
- 4 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 3 generations backK082644 GlidesheathTerumo Medical Corp. · 2008
- 2 generations backK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- 1 generation backK111606 Pinnacle Precision Access SystemTerumo Medical Corp. · 2011 · Recalled
- This deviceK252441 Primero Safe Access SystemSouth53, LLC · 2025
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set5 generations back · 1981
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −5 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −4 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −3 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| −2 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| −1 | K111606 | Pinnacle Precision Access System | Terumo Medical Corp. | 2011 | 1 |
| 0 (this device) | K252441 | Primero Safe Access System | South53, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 1 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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.
1 device in this family has a Class I recall. 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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 |
|---|---|---|---|
| * | K111606 | Pinnacle Precision Access SystemSummary page 5….1340 Product Code: DYB Class: II PREDICATE DEVICE Pinnacle Precision Access System (K111606) REFERENCE DEVICE Arrow Nitinol Wire w/ Advancer (K241784) DESCRIPTION OF THE DEVICE: The Primero Safe Access… | 2011 |
| † | K241784 | Arrow® Nitinol Wire | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 5 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K111606.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The Primero Safe Access System is intended to facilitate placing a catheter through the skin into a vein or artery. The introducer needle is used in facilitating entry through the skin into a vein or artery to provide a conduit for the guidewire. The guidewire is an accessory device which is used for placement of a catheter or sheath in the vein or artery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252441 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252441: Primero Safe Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252441
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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