510(k) · Cleared
ClearedStiletto Extended Dwell Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Piper Access, LLC · PND Midline Catheter
Cleared on Aug 27, 2021 as substantially equivalent to K162377 (C.R. Bard, Inc., 2016) after a 231-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Aug 27, 2021
- Review
- 231 days
- Class
- Class II
- Product code
- PND
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K932323 (1993). 25 ancestors in all, the oldest K801941 (1980). No later device cites it as a predicate yet.
- Root · 10 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 6 generations between
- 3 generations backK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- 2 generations backK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- 1 generation backK162377 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- This deviceK210047 Stiletto Extended Dwell CatheterPiper Access, LLC · 2021
Show all 10 generations
- Root · 10 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 9 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 8 generations backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- 7 generations backK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
- 6 generations backK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- 5 generations backK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- 4 generations backK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- 3 generations backK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- 2 generations backK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- 1 generation backK162377 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- This deviceK210047 Stiletto Extended Dwell CatheterPiper Access, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −9 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −8 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| −7 | K090372 | The Wand Microaccess Safety Introducer | Access Scientific, Inc. | 2009 | — |
| −6 | K093022 | The Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| −5 | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| −4 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| −3 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| −2 | K153280 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| −1 | K162377 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| 0 (this device) | K210047 | Stiletto Extended Dwell Catheter | Piper Access, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 2 | 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 PND? 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 PND device
- #1 K252402 Midline Catheterscore 13.2 · 10 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 |
|---|---|---|---|
| * | K162377 | PowerGlide Pro Midline CatheterSummary page 4…Intravascular Catheter, Therapeutic, Short-Term Less Than 30 Days Classification Name: Intravascular catheter Premarket Notification: K162377 Product Code: FOZ Manufacturer: Bard Access Systems, Inc. IV. DEVICE DESCRIPTION T… | 2016 |
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 28 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 25 ancestors have a recall of any class.
- 3 other devices also cite its predicate K162377.
How does its category compare?
All PND devicesPND Midline Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PND
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PND
134in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PND
4so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · PND
141in 2025
MAUDE reports naming product code PND, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 3 | 106 | 0 | 5 |
| 2017 | 3 | 134 | 0 | 23 |
| 2018 | 2 | — | 0 | 19 |
| 2019 | 1 | — | 1 | 59 |
| 2020 | 0 | — | 2 | 93 |
| 2021 | 1 | — | 0 | 86 |
| 2022 | 2 | — | 1 | 178 |
| 2023 | 0 | — | 0 | 138 |
| 2024 | 0 | — | 0 | 168 |
| 2025 | 1 | — | 0 | 141 |
| 2026 | 0 | — | 4 (1) | — |
What is it indicated for?
The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (<28 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Stiletto Extended Dwell Catheter is suitable for use with power injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210047: Stiletto Extended Dwell Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210047
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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