510(k) · Cleared
ClearedSafeSept® Transseptal Guidewire (SS-140)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pressure Products Medical Device Manufacturing, LLC · DRC Trocar
Cleared on Sep 14, 2022 as substantially equivalent to K170671 (Pressure Products Medical Device Manufacturing, LLC, 2017) after a 93-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Sep 14, 2022
- Review
- 93 days
- Class
- Class II
- Product code
- DRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K081986 (2008). No later device cites it as a predicate yet.
- Root · 2 generations backK081986 Safesept Transseptal Trocar GuidewireOscor, Inc. · 2008
- 1 generation backK170671 SafeSept Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC · 2017
- This deviceK221707 SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K081986 | Safesept Transseptal Trocar Guidewire | Oscor, Inc. | 2008 | — |
| −1 | K170671 | SafeSept Transseptal Guidewire | Pressure Products Medical Device Manufacturing, LLC | 2017 | — |
| 0 (this device) | K221707 | SafeSept® Transseptal Guidewire (SS-140) | Pressure Products Medical Device Manufacturing, LLC | 2022 | — |
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 DRC? 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 DRC device
- #1 K241042 SafeSharp Transseptal Needle (CLICK071…score 9.2 · 7 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 |
|---|---|---|---|
| * | K170671 | SafeSept Transseptal GuidewireSummary page 4…Common/Usual Name: SafeSept Product Code: DRC Equivalent Legally Marketed Devices Pressure Products Medical Device Manufacturing LLC., SafeSept® Transseptal Guidewire, K170671 Description of the Device The SafeSept® .018” Transseptal Guidewire is made of nitinol, a flexible memory wire material, device… | 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 14 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All DRC devicesDRC Trocar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DRC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DRC
Too few DRC 510(k)s in any year since 2007 to give a median.
Recalls per year · DRC
1in 2021
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRC
69in 2025
MAUDE reports naming product code DRC, 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 | 1 | — | 0 | 106 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 17 |
| 2010 | 0 | — | 1 | 33 |
| 2011 | 1 | — | 0 | 68 |
| 2012 | 1 | — | 0 | 58 |
| 2013 | 1 | — | 1 | 37 |
| 2014 | 2 | — | 1 | 65 |
| 2015 | 0 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 62 |
| 2017 | 2 | — | 0 | 70 |
| 2018 | 2 | — | 0 | 85 |
| 2019 | 0 | — | 1 (1) | 95 |
| 2020 | 0 | — | 0 | 108 |
| 2021 | 1 | — | 1 | 78 |
| 2022 | 2 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 109 |
| 2024 | 2 | — | 0 | 105 |
| 2025 | 0 | — | 0 | 69 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SafeSept® is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221707 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221707: SafeSept® Transseptal Guidewire (SS-140).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221707
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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