510(k) · Cleared
ClearedSafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
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 May 17, 2024 as substantially equivalent to K172950 (Pressure Products Medical Device Manufacturing, LLC, 2018) after a 30-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- May 17, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- DRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K964518 (1997). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
- 6 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
- 5 generations backK052644 Swartz Braided Transseptal Guiding IntroducerSt Jude Medical · 2005
- 4 generations backK070417 Across Transseptal Access System, 406977, 406978, 406979, 406980…St Jude Medical · 2007
- 3 generations backK072278 BRK Transseptal NeedleSt Jude Medical · 2007
- 2 generations backK122587 BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207…St Jude Medical · 2013
- 1 generation backK172950 TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC · 2018
- This deviceK241042 SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | 1997 | 4 |
| −6 | K042623 | Agilis Steerable Catheter Introducer, Model 408304 | St. Jude Medical, Daig Division, Inc. | 2005 | 1 |
| −5 | K052644 | Swartz Braided Transseptal Guiding Introducer | St Jude Medical | 2005 | — |
| −4 | K070417 | Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981… | St Jude Medical | 2007 | — |
| −3 | K072278 | BRK Transseptal Needle | St Jude Medical | 2007 | — |
| −2 | K122587 | BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208 | St Jude Medical | 2013 | — |
| −1 | K172950 | TSN Transseptal Needle | Pressure Products Medical Device Manufacturing, LLC | 2018 | — |
| 0 (this device) | K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) | Pressure Products Medical Device Manufacturing, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 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 K212625 PathBuilder Transseptal Needlescore 4.5 · 6 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 |
|---|---|---|---|
| * | K172950 | TSN Transseptal NeedleSummary page 5…/Usual Name: Transseptal Sharp Needle Product Code: DRC Equivalent Legally Marketed Devices Pressure Products Medical Device Manufacturing LLC., TSN Transseptal Needle, K172950 (primary predicate) Pressure Products Medical Device Manufacturing LLC., SafeSept Transseptal Guidewire, K170671 (reference devic… | 2018 |
| † | K170671 | SafeSept 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 27 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 4 of the 9 ancestors have a recall of any class.
How does its category compare?
All DRC devicesDRC Trocar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Needle is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241042: SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241042
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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