510(k) · Cleared
ClearedRespiguide Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respicardia · DQY Catheter, Percutaneous
Cleared on Oct 17, 2013 as substantially equivalent to K121051 (Merit Medical Systems, Inc., 2012) and 2 other predicates after a 245-day review. Its family tree reaches back 3 generations to 2000. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 17, 2013
- Review
- 245 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000659 (2000). 8 ancestors in all, the oldest K915414 (1992). No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK000659 Modification to Softouch Diagnostic Intravascular CatMerit Medical Systems, Inc. · 2000 · Recalled
- 2 generations backK053171 Merit Impress Diagnostic CatheterMerit Medical Systems, Inc. · 2006
- 1 generation backK093004 Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc. · 2010
- This deviceK130378 Respiguide Delivery SystemRespicardia · 2013
Class I recalls in this family
- K001578 Angiodynamics Soft-VU Hydrophilic Coated…2 generations back · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000659 | Modification to Softouch Diagnostic Intravascular Cat | Merit Medical Systems, Inc. | 2000 | 1 |
| −2 | K053171 | Merit Impress Diagnostic Catheter | Merit Medical Systems, Inc. | 2006 | — |
| −1 | K093004 | Impress Angiographic Catheter with Hydrophilic Coating | Merit Medical Systems, Inc. | 2010 | — |
| 0 (this device) | K130378 | Respiguide Delivery System | Respicardia | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 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 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? (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 |
|---|---|---|---|
| * | K121051 | Concierge Guiding CatheterSummary page 1…Diagnostic Catheter Review Panel: Cardiovascular Predicate Device 1: Merit Medical Systems, Inc. 6F Concierge Guide Catheter (K12 1051) Predicate Device 2: Merit Medical Systems, Inc. 5F Impress Angiographic Catheter (K053171, K093004) Tradi… | 2012 |
| * | K053171 | Merit Impress Diagnostic CatheterSummary page 1…Predicate Device 1: Merit Medical Systems, Inc. 6F Concierge Guide Catheter (K12 1051) Predicate Device 2: Merit Medical Systems, Inc. 5F Impress Angiographic Catheter (K053171, K093004) Traditional 510(k) Prcmnarket Notification 10iI(k) Notification')… | 2006 |
| * | K093004 | Impress Angiographic Catheter with Hydrophilic CoatingSummary page 1…e Device 1: Merit Medical Systems, Inc. 6F Concierge Guide Catheter (K12 1051) Predicate Device 2: Merit Medical Systems, Inc. 5F Impress Angiographic Catheter (K053171, K093004) Traditional 510(k) Prcmnarket Notification 10iI(k) Notification')… | 2010 |
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.
- K001578Angiodynamics Soft-VU Hydrophilic Coated Angiographic CatheterAngioDynamics, Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K121051.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Respiguide outer guide catheter: The guide catheter is intended for use for intravascular introduction of interventional/diagnostic devices into peripheral vascular systems.
Respiguide inner (angiographic) catheter: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
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/K130378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130378: Respiguide Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130378
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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