510(k) · Cleared
ClearedSafeSept Transseptal Guidewire
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 Oct 20, 2017 as substantially equivalent to K081986 (Oscor, Inc., 2008) after a 228-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.
- Decided
- Oct 20, 2017
- Review
- 228 days
- Class
- Class II
- Product code
- DRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081986 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK081986 Safesept Transseptal Trocar GuidewireOscor, Inc. · 2008
- This deviceK170671 SafeSept Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC · 2017
- Descendant · cites it directly · 0 of its ownK221707 SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081986 | Safesept Transseptal Trocar Guidewire | Oscor, Inc. | 2008 | — |
| 0 (this device) | K170671 | SafeSept Transseptal Guidewire | Pressure Products Medical Device Manufacturing, LLC | 2017 | — |
| +1 | K221707 | SafeSept® Transseptal Guidewire (SS-140) | Pressure Products Medical Device Manufacturing, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 |
|---|---|---|---|
| * | K081986 | Safesept Transseptal Trocar GuidewireSummary page 4…ame: Trocar (CFR 870.1390) Common/Usual Name: Transseptal Guidewire Product Code: DRC Equivalent Legally Marketed Devices Oscor, SafeSept® Transseptal Trocar Guidewire, K081986 Description of the Devices The SafeSept® Transseptal Guidewire is 0.014” in diameter and 135cm long and consists of a flexible m… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221707 | SafeSept® Transseptal Guidewire (SS-140) | 2022 | 0 |
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.
- Of its descendants, K221707 (Pressure Products Medical Device Manufacturing, LLC, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRC devicesDRC Trocar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The 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/K170671 · printed Nov 3, 2026
Cite this page
510(k) Report. “K170671: SafeSept Transseptal Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K170671
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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