510(k) · Cleared
ClearedSynox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and 120 143
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DTB Permanent Pacemaker Electrode
Cleared on Sep 10, 1998 after a 188-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Sep 10, 1998
- Review
- 188 days
- Class
- Class III
- Product code
- DTB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK980869 Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119…Biotronik, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK994240 EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model…Biotronik, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK023205 Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK991169 SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854Biotronik, Inc. · 1999
Most influential descendants
Showing 3 of 3 · See all- K994240EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133Biotronik, Inc. · 2000 · cites it directly1descendant
- K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPBiotronik, Inc. · 2003 · cites it directly0descendants
- K991169SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854Biotronik, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980869 | Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120… | Biotronik, Inc. | 1998 | — |
| +1 | K994240 | EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133 | Biotronik, Inc. | 2000 | — |
| +1 | K023205 | Elox P 45-BP; Elox P 53-BP; Elox P 60-BP | Biotronik, Inc. | 2003 | — |
| +1 | K991169 | SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854 | Biotronik, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 DTB? 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | BIOTRONIK POLYROX lead Named without a submission number |
What descends from it? (3)
3 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, K994240 (Biotronik, Inc., 2000) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DTB devicesDTB Permanent Pacemaker Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTB
Too few DTB 510(k)s in any year since 2007 to give a median.
Recalls per year · DTB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTB
25,591in 2025
MAUDE reports naming product code DTB, 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 | 5,401 |
| 2008 | 0 | — | 1 | 6,469 |
| 2009 | 0 | — | 2 | 7,565 |
| 2010 | 0 | — | 2 | 14,285 |
| 2011 | 0 | — | 0 | 12,555 |
| 2012 | 0 | — | 0 | 12,230 |
| 2013 | 0 | — | 0 | 10,102 |
| 2014 | 0 | — | 0 | 13,324 |
| 2015 | 3 | — | 1 | 11,071 |
| 2016 | 8 | — | 0 | 11,839 |
| 2017 | 5 | — | 0 | 11,495 |
| 2018 | 6 | — | 0 | 15,209 |
| 2019 | 7 | — | 0 | 16,812 |
| 2020 | 6 | — | 0 | 17,859 |
| 2021 | 3 | — | 0 | 18,442 |
| 2022 | 4 | — | 0 | 19,444 |
| 2023 | 7 | — | 0 | 34,542 |
| 2024 | 3 | — | 0 | 25,689 |
| 2025 | 1 | — | 0 | 25,591 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
SYNOX leads are designed for use with implantable pulse generators which require pacing leads
with a bipolar 3.2 mm IS-1 connector configuration; they may be used with single or dual
chamber pacing systems. The leads are designed for use in patients for whom single or dual
chamber pulse generator therapy is medically indicated. This indication follows that
recommended in the Class I definition of the ACC/AHA Task Force Report, entitled “Guidelines
for Implantation of Cardiac Pacemakers and Antiarrhythmic Devices” (JACC, Vol. 18. No. 1,
July 1991:1 - 13).
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/K980869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980869: Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and 120 143.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980869
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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