PMA · Approved
ApprovedCool Point™ Tubing Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Biomedical, Inc. · OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Approved on Dec 19, 2025 through premarket approval, which rests on the device’s own clinical evidence after a 17-day review.
- Decided
- Dec 19, 2025
- Review
- 17 days
- Class
- Class III
- Product code
- OAD
- 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 OAD? 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 OAD devicesOAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OAD
19in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAD
Too few OAD 510(k)s in any year since 2007 to give a median.
Recalls per year · OAD
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAD
196in 2025
MAUDE reports naming product code OAD, 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 | 14 | — | 0 | 2 |
| 2008 | 8 | — | 0 | 43 |
| 2009 | 9 | — | 2 | 94 |
| 2010 | 12 | — | 0 | 407 |
| 2011 | 21 | — | 0 | 486 |
| 2012 | 19 | — | 1 | 414 |
| 2013 | 30 | — | 2 | 256 |
| 2014 | 25 | — | 0 | 329 |
| 2015 | 24 | — | 4 | 274 |
| 2016 | 47 | — | 0 | 239 |
| 2017 | 64 | — | 0 | 403 |
| 2018 | 29 | — | 4 | 423 |
| 2019 | 39 | — | 0 | 475 |
| 2020 | 42 | — | 0 | 389 |
| 2021 | 50 | — | 0 | 402 |
| 2022 | 20 | — | 1 | 344 |
| 2023 | 19 | — | 0 | 319 |
| 2024 | 19 | — | 0 | 290 |
| 2025 | 19 | — | 0 | 196 |
| 2026 | 14 | — | 1 | — |
https://510kreport.com/device/P060019/S058 · printed Nov 6, 2026
Cite this page
510(k) Report. “P060019/S058: Cool Point™ Tubing Set.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P060019/S058
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026