510(k) · Cleared
Recalled · Class II · 2016Pinnacle Precision Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DYB Introducer, Catheter
Cleared on Oct 3, 2011 as substantially equivalent to K954234 (Terumo Medical Corp., 1995) and 1 other predicate after a 116-day review. Its family tree reaches back 5 generations to 1995. 1 of the 18 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 3, 2011
- Review
- 116 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954234 (1995). 10 ancestors in all, the oldest K810675 (1981). 7 later devices descend from it, 3 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 4 generations backK033681 GlidesheathTerumo Corp. · 2003
- 3 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 2 generations backK082644 GlidesheathTerumo Medical Corp. · 2008
- 1 generation backK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- This deviceK111606 Pinnacle Precision Access SystemTerumo Medical Corp. · 2011
- Descendant · cites it directly · 3 of its ownK123475 Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK152177 SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK140768 Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit…Lepu Medical Technology (Bejing) Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK252441 Primero Safe Access SystemSouth53, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK243061 SonoStik Guide Wire IntroducerSonostik, LLC · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set4 generations back · 1981
Most influential descendants
Showing 5 of 7 · See all- K123475Shoocin Introducer KitLepu Medical Technology (Beijing) Co., Ltd. · 2014 · cites it directly3descendants
- K152177SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015 · cites it directly1descendant
- K140768Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii Brilliant…Lepu Medical Technology (Bejing) Co., Ltd. · 2014 · 2 generations on1descendant
- K252441Primero Safe Access SystemSouth53, LLC · 2025 · cites it directly0descendants
- K243061SonoStik Guide Wire IntroducerSonostik, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −4 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −3 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −2 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| −1 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| 0 (this device) | K111606 | Pinnacle Precision Access System | Terumo Medical Corp. | 2011 | — |
| +1 | K123475 | Shoocin Introducer Kit | Lepu Medical Technology (Beijing) Co., Ltd. | 2014 | — |
| +1 | K152177 | SonoStik IV Guide Wire Introducer | Sonostik, LLC | 2015 | — |
| +2 | K140768 | Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type Iii… | Lepu Medical Technology (Bejing) Co., Ltd. | 2014 | — |
| +1 | K252441 | Primero Safe Access System | South53, LLC | 2025 | — |
| +2 | K243061 | SonoStik Guide Wire Introducer | Sonostik, LLC | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K954234 | Radifocus Introducer II KitSummary page 2…s of the Pinnacle Precision Access System in this submission (the Sheath and Dilator) are unchanged from those of the Radifocus Introducer 11 predicate device (K954234). The Pinnacle Precision Access System differs from the Radifocus Introducer 11 predicate device in the addition of the meta… | 1995 |
| * | K102008 | GlidesheathSummary page 8…, design, technology/principles of operation, materials and performance to the predicate devices the Radifocus Introducer 11 (K954234) and the Glidesheath (K102008). Differences between the devices do not raise any significant issues of safety or effectiveness. J. Submitter… | 2010 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2016 | Class II | Z-2738-2016 | Device Design | Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve. |
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 · 4 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K123475 (Lepu Medical Technology (Beijing) Co., Ltd., 2014) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K954234.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Pinnacle Precision Access System is used to facilitate planing a catheter through the skin into a vein or artery.
The Entry Needle is an accessory device which is used to gain access to the vein or artery, for placement of the Mini Guide Wire.
The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111606: Pinnacle Precision Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111606
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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