510(k) · Cleared
ClearedCCS Maestro (R) II Series 200 Models 235 and 227 Cardiac Pacemaker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Control Systems, Inc. · DXY Implantable Pacemaker Pulse-Generator
Cleared on May 3, 1995 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- May 3, 1995
- Review
- 104 days
- Class
- Class III
- Product code
- DXY
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXY? 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 DXY devicesDXY Implantable Pacemaker Pulse-Generator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXY
19in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXY
Too few DXY 510(k)s in any year since 2007 to give a median.
Recalls per year · DXY
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXY
810in 2025
MAUDE reports naming product code DXY, 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 | 0 | — | 0 | 2,407 |
| 2008 | 0 | — | 0 | 2,649 |
| 2009 | 0 | — | 6 | 3,750 |
| 2010 | 0 | — | 1 | 4,187 |
| 2011 | 0 | — | 2 | 6,050 |
| 2012 | 0 | — | 0 | 3,709 |
| 2013 | 0 | — | 0 | 2,682 |
| 2014 | 0 | — | 0 | 5,604 |
| 2015 | 0 | — | 0 | 1,022 |
| 2016 | 15 | — | 0 | 542 |
| 2017 | 51 | — | 4 | 1,047 |
| 2018 | 45 | — | 0 | 2,070 |
| 2019 | 19 | — | 0 | 1,799 |
| 2020 | 23 | — | 0 | 546 |
| 2021 | 20 | — | 0 | 560 |
| 2022 | 14 | — | 0 | 784 |
| 2023 | 19 | — | 0 | 922 |
| 2024 | 20 | — | 0 | 773 |
| 2025 | 19 | — | 0 | 810 |
| 2026 | 19 | — | 0 | — |
https://510kreport.com/device/K950210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950210: CCS Maestro (R) II Series 200 Models 235 and 227 Cardiac Pacemaker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950210
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026