510(k) · Cleared
ClearedBaylis Connector Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Technologies, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Jan 18, 2026 as substantially equivalent to K230571 (Baylis Medical Technologies, Inc., 2023) after a 30-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Jan 18, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K230571 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backK230571 RFP-100A Connector Cable (Single Use)Baylis Medical Technologies, Inc. · 2023
- This deviceK254114 Baylis Connector CableBaylis Medical Technologies, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K230571 | RFP-100A Connector Cable (Single Use) | Baylis Medical Technologies, Inc. | 2023 | — |
| 0 (this device) | K254114 | Baylis Connector Cable | Baylis Medical Technologies, Inc. | 2026 | — |
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 DSA? 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 DSA device
- #1 K252827 IBP cable Becton Dickinson (2606488); IBP…score 11.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K230571 | RFP-100A Connector Cable (Single Use)Summary page 5…Device Class: Class II Product Code: DSA I1l. Identification of Predicate Device Predicate Device: RFP-100A Connector Cable (Single Use), cleared under 510(K) number K230571 Predicate Device Manufacturer: Baylis Medical Technologies Inc. Recall Status: Predicate device has not been the subject of a d… | 2023 |
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.
How does its category compare?
All DSA devicesDSA Cable, Transducer And Electrode, Patient, (Including Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DSA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSA
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSA
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSA
67in 2025
MAUDE reports naming product code DSA, 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 | 2 | — | 0 | 4 |
| 2008 | 6 | 59 | 0 | 11 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 4 | 55 | 2 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 23 |
| 2014 | 1 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 2 | — | 0 | 28 |
| 2017 | 5 | 140 | 0 | 5 |
| 2018 | 3 | 84 | 0 | 16 |
| 2019 | 4 | 140 | 0 | 11 |
| 2020 | 6 | 177 | 0 | 31 |
| 2021 | 4 | 164 | 0 | 7 |
| 2022 | 2 | — | 1 | 49 |
| 2023 | 3 | 240 | 0 | 29 |
| 2024 | 3 | 102 | 0 | 40 |
| 2025 | 4 | 105 | 0 | 67 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Baylis Connector Cable is intended to connect Baylis Radiofrequency (RF) Puncture Generators to separately cleared compatible RF devices.
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/K254114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254114: Baylis Connector Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254114
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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