510(k) · Cleared
ClearedPikos 01 & Pikos E 01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, GmbH & Co. · DXY Implantable Pacemaker Pulse-Generator
Cleared on Feb 26, 1992 after a 166-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Feb 26, 1992
- Review
- 166 days
- Class
- Class III
- Product code
- DXY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK914109 Pikos 01 & Pikos E 01Biotronik, GmbH & Co. · 1992
- Descendant · cites it directly · 0 of its ownK993434 Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-a, Pikos E01-aBiotronik, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK945627 Pikos LP 01, Pikos LP E01Biotronik, Inc. · 1996
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914109 | Pikos 01 & Pikos E 01 | Biotronik, GmbH & Co. | 1992 | — |
| +1 | K993434 | Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-a, Pikos E01-a | Biotronik, Inc. | 1999 | — |
| +1 | K945627 | Pikos LP 01, Pikos LP E01 | Biotronik, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
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? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K993434 (Biotronik, Inc., 1999) has gone furthest, with 0 descendants of its own.
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/K914109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914109: Pikos 01 & Pikos E 01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914109
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026