510(k) · Cleared
ClearedBiotronik Stylets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DRB Stylet, Catheter
Cleared on Aug 1, 2019 as substantially equivalent to K090163 (St Jude Medical, 2009) after a 59-day review. Its family tree reaches back 2 generations to 1996. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 1, 2019
- Review
- 59 days
- Class
- Class II
- Product code
- DRB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P950022 (1996). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP950022 TVL (TM) Lead SystemAbbott Medical · 1996 · Recalled (Class I)
- 1 generation backK090163 Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical · 2009
- This deviceK191469 Biotronik StyletsBiotronik, Inc. · 2019
Class I recalls in this family
- P950022 TVL (TM) Lead System2 generations back · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950022 | TVL (TM) Lead System | Abbott Medical | 1996 | Class I |
| −1 | K090163 | Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078 | St Jude Medical | 2009 | — |
| 0 (this device) | K191469 | Biotronik Stylets | Biotronik, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRB device
- #1 K220280 Arrow Stiffening Styletscore 5.1 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K090163 | Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078Summary page 4…Stylet, Catheter Name Classification Name 21CFR870.1380 Regulatory Class II Product Code DRB 3. Predicate Device Abbott stylets (K090163, cleared April 1, 2009). 4. Device Description BIOTRONIK stylets are intended for use with long-term implantable BIOTRONIK lead… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- P950022TVL (TM) Lead SystemAbbott Medical · 1996 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DRB devicesDRB Stylet, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DRB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DRB
Too few DRB 510(k)s in any year since 2007 to give a median.
Recalls per year · DRB
No recall names DRB since 2007.
Adverse event reports per year · DRB
152in 2025
MAUDE reports naming product code DRB, 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 | 0 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 54 |
| 2011 | 0 | — | 0 | 28 |
| 2012 | 0 | — | 0 | 40 |
| 2013 | 0 | — | 0 | 53 |
| 2014 | 1 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 66 |
| 2016 | 0 | — | 0 | 56 |
| 2017 | 1 | — | 0 | 63 |
| 2018 | 0 | — | 0 | 40 |
| 2019 | 2 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 92 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 0 | 94 |
| 2023 | 0 | — | 0 | 82 |
| 2024 | 0 | — | 0 | 116 |
| 2025 | 0 | — | 0 | 152 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BIOTRONIK Stylets are used in conjunction with the implantation of implantable systems (leads and pacemakers or ICD). Therefore, the same indications and contraindications that apply for the designated active implant and leads, also apply for stylets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191469: Biotronik Stylets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191469
Report an extraction error
Are you the manufacturer?
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