510(k) · Cleared
ClearedBard Atlas Pta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DQY Catheter, Percutaneous
Cleared on Feb 13, 2004 as substantially equivalent to K014212 (C.R. Bard, Inc., 2002) and 1 other predicate after a 10-day review. Its family tree reaches back 2 generations to 1993. 11 later devices descend from it.
- Decided
- Feb 13, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933483 (1993). 4 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- 1 generation backK973013 Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc. · 1998
- This deviceK040243 Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK052236 Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005
- Descendant · 2 generations on · 9 of its ownK120971 Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012
- Descendant · 3 generations on · 7 of its ownK122984 Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012
- Descendant · 3 generations on · 5 of its ownK122367 Bard PTV Dilatation CatheterC.R. Bard, Inc. · 2012
- Descendant · 4 generations on · 4 of its ownK181323 Atlas Gold PTA Dilatation CatheterC.R. Bard, Inc. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K052236Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005 · cites it directly10descendants
- K120971Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012 · 2 generations on9descendants
- K122984Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012 · 3 generations on7descendants
- K122367Bard PTV Dilatation CatheterC.R. Bard, Inc. · 2012 · 3 generations on5descendants
- K181323Atlas Gold PTA Dilatation CatheterC.R. Bard, Inc. · 2018 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933483 | Opti-Plast 5F Pta Catheters | Vas-Cath, Inc. | 1993 | — |
| −1 | K973013 | Opti-Plast (Centurion) 5.5F Angioplasty Catheter | Vas-Cath, Inc. | 1998 | — |
| 0 (this device) | K040243 | Bard Atlas Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2004 | — |
| +1 | K052236 | Bard Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2005 | — |
| +2 | K120971 | Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2012 | — |
| +3 | K122984 | Atlas Gold Pta Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
| +3 | K122367 | Bard PTV Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
| +4 | K181323 | Atlas Gold PTA Dilatation Catheter | C.R. Bard, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K014212 | Bard Conquest Pta Balloon Dilatation CatheterSummary page 1…C. Predicate Device Name(s): Bard® ConquestTM PTA Balloon Dilatation Catheter (K014212, cleared 01/17/02) Bard T M Opti-Plast® Centurion TM 5.5F PTA Catheter… | 2002 |
| * | K973013 | Opti-Plast (Centurion) 5.5F Angioplasty CatheterSummary page 1…, cleared 01/17/02) Bard T M Opti-Plast® Centurion TM 5.5F PTA Catheter (K973013, cleared 06/19/98) D. Device Description: The Bard® Atlas TM PTA Balloon Dilatation Catheter is… | 1998 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052236 | Bard Atlas Pta Balloon Dilatation Catheter | 2005 | 10 |
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 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K052236 (Bard Peripheral Vascular, Inc., 2005) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K014212.
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 Bard® Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040243 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040243: Bard Atlas Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040243
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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