510(k) · Cleared
ClearedLead Stylet,Models 6505,6506,6507,6508
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · DRB Stylet, Catheter
Cleared on Nov 12, 1999 as substantially equivalent to K905674 (Cardiac Pacemakers, Inc., 1991) after a 79-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Nov 12, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- DRB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K905674 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK905674 Lead StyletCardiac Pacemakers, Inc. · 1991
- This deviceK992863 Lead Stylet,Models 6505,6506,6507,6508Guidant Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905674 | Lead Stylet | Cardiac Pacemakers, Inc. | 1991 | — |
| 0 (this device) | K992863 | Lead Stylet,Models 6505,6506,6507,6508 | Guidant Corp. | 1999 | — |
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 DRB? 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? (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 |
|---|---|---|---|
| Kept off the family tree | K893957 | stylets currently packaged with leads Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Which Equivalence is Claimed: With the exception of a difference in length, the stylets in the new accessory kits are identical to stylets currently packaged with leads (K893957, cleared 7/14/89 and K932103, cleared 12/8/93). With respect to packaging, the new accessory Kkits are identical to the currently… | |
| Kept off the family tree | K932103 | stylets currently packaged with leads Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…With the exception of a difference in length, the stylets in the new accessory kits are identical to stylets currently packaged with leads (K893957, cleared 7/14/89 and K932103, cleared 12/8/93). With respect to packaging, the new accessory Kkits are identical to the currently marketed Accessory Stylet Ki… | |
| * | K905674 | Lead StyletSummary page 1…2103, cleared 12/8/93). With respect to packaging, the new accessory Kkits are identical to the currently marketed Accessory Stylet Kit Models 6501, 6502, 6503 and 6504 (K905674, cleared 1/30/91). Intended Use: These stylets are wires intended to facilitate the placement of pacing leads during pacemaker… | 1991 |
| † | P930060 | previous stylets |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K905674.
How does its category compare?
All DRB devicesDRB Stylet, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
These stylets are wires intended to facilitate the placement of pacmg leads during pacemaker implant procedures.
The straight stylets are used to direct passage of a lead to the appropriate heart chamber and to wedge the lead in the trabeculae of the ventricle.
The J-shaped stylets are used to direct passage of a lead in the atrium.
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/K992863 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992863: Lead Stylet,Models 6505,6506,6507,6508.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992863
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