510(k) · Cleared
ClearedSafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pressure Products Medical Device Manufacturing, LLC · DXF Catheter, Septostomy
Cleared on Mar 13, 2026 as substantially equivalent to K242076 (Baylis Medical Company, 2024) after a 105-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Mar 13, 2026
- Review
- 105 days
- Class
- Class II
- Product code
- DXF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011727 (2002). 6 ancestors in all, the oldest K990284 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK011727 Transseptal Needle/TrocarThomas Medical Products, Inc. · 2002 · Recalled
- 3 generations backK073326 NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008 · Recalled
- 2 generations backK150709 ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · Recalled
- 1 generation backK242076 VersaCross™ RF WireBaylis Medical Company · 2024
- This deviceK253799 SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232…Pressure Products Medical Device Manufacturing, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011727 | Transseptal Needle/Trocar | Thomas Medical Products, Inc. | 2002 | 1 |
| −3 | K073326 | NRG Transseptal Needle | Baylis Medical Co., Inc. | 2008 | 1 |
| −2 | K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | 2015 | 1 |
| −1 | K242076 | VersaCross™ RF Wire | Baylis Medical Company | 2024 | — |
| 0 (this device) | K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R… | Pressure Products Medical Device Manufacturing, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 DXF? 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 DXF device
- #1 K242076 VersaCross™ RF Wirescore 14.9 · 3 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 |
|---|---|---|---|
| * | K242076 | VersaCross™ RF WireSummary page 5…er (21 CFR §870.5175) Common/Usual Name: RF Transseptal Guidewire Product Code: DXF Legally Marketed Predicate Device Baylis Medical Company Inc., VersaCrossTM RF Wire, K242076 Reference Device Pressure Products Medical Device Manufacturing LLC., SafeSept Needle Free Transseptal Guidewire, K172893 Descr… | 2024 |
| † | K172893 | SafeSept Needle Free Transseptal Guidewire | 2017 |
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K242076.
How does its category compare?
All DXF devicesDXF Catheter, Septostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DXF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXF
83in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXF
3in 2020
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DXF
682in 2025
MAUDE reports naming product code DXF, 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 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 0 | — | 1 | 13 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 36 |
| 2019 | 1 | — | 0 | 24 |
| 2020 | 0 | — | 3 (3) | 55 |
| 2021 | 1 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 70 |
| 2023 | 1 | — | 0 | 286 |
| 2024 | 4 | 83 | 0 | 368 |
| 2025 | 2 | — | 0 | 682 |
| 2026 | 3 | 30 | 0 | — |
What is it indicated for?
The SafeSept RF Transseptal Guidewire is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept RF Transseptal Guidewire is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253799: SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253799
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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