510(k) · Cleared
ClearedPrecious Plus Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · DQY Catheter, Percutaneous
Cleared on Sep 17, 2007 as substantially equivalent to K061601 (Asahi Intecc Co., Ltd., 2006) and 1 other predicate after a 31-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Sep 17, 2007
- Review
- 31 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010874 (2001). 5 ancestors in all, the oldest K953987 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK010874 6F Mach 1, Model 34356-XXXBoston Scientific Corp · 2001 · Recalled
- 2 generations backK020028 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F…Boston Scientific · 2002 · Recalled
- 1 generation backK061601 Asahi Precious Guide CatheterAsahi Intecc Co., Ltd. · 2006
- This deviceK072316 Precious Plus Guide CatheterAsahi Intecc Co., Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010874 | 6F Mach 1, Model 34356-XXX | Boston Scientific Corp | 2001 | 11 |
| −2 | K020028 | 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX | Boston Scientific | 2002 | 11 |
| −1 | K061601 | Asahi Precious Guide Catheter | Asahi Intecc Co., Ltd. | 2006 | — |
| 0 (this device) | K072316 | Precious Plus Guide Catheter | Asahi Intecc Co., Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 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.
Planning a device in DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K061601 | Asahi Precious Guide CatheterSummary page 1…Percutaneous Catheter DEVICE Class 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: Asahi Precious Guide Catheter - K061601 Guidant ACS Viking Guiding Catheter - K972484 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: T… | 2006 |
| * | K972484 | Acs Viking Guiding CatheterSummary page 1…21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: Asahi Precious Guide Catheter - K061601 Guidant ACS Viking Guiding Catheter - K972484 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Precious plus guide catheter is intended for use in coronary… | 1997 |
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 6 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 3 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K061601.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Precious Plus Guide Catheter is intended for use in coronary artery applications and
is designed to provide a pathway through which medical instruments, such as balloon
catheters, guide wires or other therapeutic devices may be introduced. These devices
are not intended for use in the cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072316 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072316: Precious Plus Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072316
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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