510(k) · Cleared
ClearedPikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-a, Pikos E01-a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DXY Implantable Pacemaker Pulse-Generator
Cleared on Nov 10, 1999 as substantially equivalent to K914109 (Biotronik, GmbH & Co., 1992) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Nov 10, 1999
- Review
- 29 days
- Class
- Class III
- Product code
- DXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K914109 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914109 Pikos 01 & Pikos E 01Biotronik, GmbH & Co. · 1992
- This deviceK993434 Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-a, Pikos E01-aBiotronik, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914109 | Pikos 01 & Pikos E 01 | Biotronik, GmbH & Co. | 1992 | — |
| 0 (this device) | K993434 | Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-a, Pikos E01-a | Biotronik, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
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 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914109 | Pikos 01 & Pikos E 01Summary page 1…PR 1000"-VS programmer (dated P950037/S8, dated 08-24-99). The affected members of the Pikos family are comprised of the following pulse generators. Table 1 | Pikos EO1 K914109A Full I1S-1 Pikos 01-A K923026C Full 5-mm Pikos EO1-A K923026C Full 5-mm Pikos 01-B K9141937 Full 6-mm Pikos E01-B K9141937 Full… | 1992 |
| * | K923026 | Pikos 01-a and Pikos E01-a Implantable PacemakerSummary page 1…950037/S8, dated 08-24-99). The affected members of the Pikos family are comprised of the following pulse generators. Table 1 | Pikos EO1 K914109A Full I1S-1 Pikos 01-A K923026C Full 5-mm Pikos EO1-A K923026C Full 5-mm Pikos 01-B K9141937 Full 6-mm Pikos E01-B K9141937 Full 6-mm Unlocking the NIPS featur… | 1993 |
| Kept off the family tree | K914193 | FDA’s K914193 is A&E Medical Corp Dispos Suct Coag W/Non Stick Coat Our OCR of the scanned summary read K914193, FDA’s number for A&E Medical Corp Dispos Suct Coag W/Non Stick Coat (Alto Development Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Pikos 01-B”. Kept off the family tree. Summary page 1…family are comprised of the following pulse generators. Table 1 | Pikos EO1 K914109A Full I1S-1 Pikos 01-A K923026C Full 5-mm Pikos EO1-A K923026C Full 5-mm Pikos 01-B K9141937 Full 6-mm Pikos E01-B K9141937 Full 6-mm Unlocking the NIPS feature within the programmer software allows a previously implante… | 1992 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K914109.
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 | — |
What is it indicated for?
Pikos single chamber pacemakers, Models 01/01-A/E01/LP 01/LP E01/E01-B pacemakers are indicated for the following:
Symptomatic paroxysmal or permanent second or third-degree AV block
Symptomatic bilateral bundle branch block
Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders
Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias
Vasovagal syndromes or hypersensitive carotid sinus syndromes
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993434: Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-a, Pikos E01-a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993434
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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