PMA · Approved
ApprovedBioFreedom Drug Coated Coronary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosensors International USA, Inc. · NIQ Coronary Drug-Eluting Stent
Approved on Apr 14, 2022 through premarket approval, which rests on the device’s own clinical evidence after a 972-day review.
- Decided
- Apr 14, 2022
- Review
- 972 days
- Class
- Class III
- Product code
- NIQ
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NIQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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.
How does its category compare?
All NIQ devicesNIQ Coronary Drug-Eluting Stent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NIQ
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIQ
Too few NIQ 510(k)s in any year since 2007 to give a median.
Recalls per year · NIQ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NIQ
2,471in 2025
MAUDE reports naming product code NIQ, 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 | 23 | — | 0 | 4,851 |
| 2008 | 59 | — | 0 | 5,096 |
| 2009 | 88 | — | 1 | 7,106 |
| 2010 | 82 | — | 0 | 5,839 |
| 2011 | 97 | — | 0 | 7,105 |
| 2012 | 167 | — | 0 | 8,323 |
| 2013 | 99 | — | 1 | 7,563 |
| 2014 | 128 | — | 0 | 6,666 |
| 2015 | 45 | — | 0 | 6,142 |
| 2016 | 72 | — | 0 | 7,234 |
| 2017 | 53 | — | 0 | 6,786 |
| 2018 | 61 | — | 0 | 6,817 |
| 2019 | 59 | — | 0 | 7,254 |
| 2020 | 62 | — | 0 | 6,362 |
| 2021 | 63 | — | 0 | 5,268 |
| 2022 | 45 | — | 0 | 4,068 |
| 2023 | 49 | — | 0 | 3,097 |
| 2024 | 35 | — | 0 | 3,041 |
| 2025 | 28 | — | 0 | 2,471 |
| 2026 | 27 | — | 0 | — |
https://510kreport.com/device/P190020 · printed Nov 3, 2026
Cite this page
510(k) Report. “P190020: BioFreedom Drug Coated Coronary Stent System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P190020
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026