510(k) · Cleared
ClearedBiocardia Morph Universal Deflectable Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocardia, Inc. · DQY Catheter, Percutaneous
Cleared on Feb 17, 2005 as substantially equivalent to K012749 (Biocardia, Inc., 2002) and 3 other predicates after a 150-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Feb 17, 2005
- Review
- 150 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K931794 (1994). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- 2 generations backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
- 1 generation backK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
- This deviceK042553 Biocardia Morph Universal Deflectable Guide CatheterBiocardia, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK192774 BioCardia 8F Morph DNA Deflectable Guide CatheterBiocardia · 2020
- Descendant · 2 generations on · 0 of its ownK242169 Morph DNA Steerable Introducer SheathBiocardia · 2024
- Descendant · cites it directly · 0 of its ownK090999 Biocardia Morph Sheath GuideBiocardia, Inc. · 2009 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931794 | Marinr Series EP Diagnostic Catheters | Medtronic Cardiorhythm | 1994 | — |
| −2 | K974683 | Naviport Deflectable Tip Guiding Catheter | Cardima, Inc. | 1999 | — |
| −1 | K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664 | Biocardia, Inc. | 2002 | — |
| 0 (this device) | K042553 | Biocardia Morph Universal Deflectable Guide Catheter | Biocardia, Inc. | 2005 | — |
| +1 | K192774 | BioCardia 8F Morph DNA Deflectable Guide Catheter | Biocardia | 2020 | — |
| +2 | K242169 | Morph DNA Steerable Introducer Sheath | Biocardia | 2024 | — |
| +1 | K090999 | Biocardia Morph Sheath Guide | Biocardia, Inc. | 2009 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664 | 2002 |
| * | K961280 | Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10FSummary page 1…e is substantially equivalent in intended use and/or method of operation to the BioCardia Universal Deflectable Guide Catheter (KO12749), SCIMED Triguide Guide Catheter (K961280), the USCI Mainstay Guiding Catheter (K971034) and the Cardima Naviport Deflectable Tip Guiding Catheter (K974683). Intended Us… | 1996 |
| * | K971034 | Usci Mainstay Guiding CatheterSummary page 1…and/or method of operation to the BioCardia Universal Deflectable Guide Catheter (KO12749), SCIMED Triguide Guide Catheter (K961280), the USCI Mainstay Guiding Catheter (K971034) and the Cardima Naviport Deflectable Tip Guiding Catheter (K974683). Intended Use: The BioCardia Morph Universal Deflectable… | 1997 |
| * | K974683 | Naviport Deflectable Tip Guiding CatheterSummary page 1…ide Catheter (KO12749), SCIMED Triguide Guide Catheter (K961280), the USCI Mainstay Guiding Catheter (K971034) and the Cardima Naviport Deflectable Tip Guiding Catheter (K974683). Intended Use: The BioCardia Morph Universal Deflectable Guide Catheter is intended to provide a pathway through which medic… | 1999 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K192774 (Biocardia, 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K012749.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BioCardia Morph Universal Deflectable Guide Catheter is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042553 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042553: Biocardia Morph Universal Deflectable 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/K042553
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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