510(k) · Cleared
ClearedTrapIt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imds Operations B.V. · DQY Catheter, Percutaneous
Cleared on Jan 21, 2020 as substantially equivalent to K162253 (Creganna Medical Aslo Business AS Cregganna Tactx Medical, 2017) after a 258-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jan 21, 2020
- Review
- 258 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P860019 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- 2 generations backK113220 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corporation · 2012 · Recalled
- 1 generation backK162253 Trapper Exchange DeviceCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2017
- This deviceK191229 TrapItImds Operations B.V. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| −2 | K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corporation | 2012 | 1 |
| −1 | K162253 | Trapper Exchange Device | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2017 | — |
| 0 (this device) | K191229 | TrapIt | Imds Operations B.V. | 2020 | — |
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? (1)
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 |
|---|---|---|---|
| * | K162253 | Trapper Exchange DeviceSummary page 4…Classification Name Catheter, percutaneous Product Code DQY Predicate Device K162253, Trapper Exchange Device, Creganna Medical Device Description The TrapIt Trapping Balloon Catheters have an integrated shaft sys… | 2017 |
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 34 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 TrapIT Trapping Balloon Catheter is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. TrapIT Trapping Balloon Catheter is not intended for use outside of the guide catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191229: TrapIt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191229
Report an extraction error
Are you the manufacturer?
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