510(k) · Cleared
ClearedPowerGlide Pro™ Midline Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company (Bard Access Systems, Inc.) · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jul 29, 2024 as substantially equivalent to K162377 (C.R. Bard, Inc., 2016) after a 174-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Jul 29, 2024
- Review
- 174 days
- Class
- Class II
- Product code
- FOZ
- 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 deviceK240359 PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, Inc.) · 2024
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 deviceK240359 PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, Inc.) · 2024
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) | K240359 | PowerGlide Pro™ Midline Catheter | Becton, Dickinson and Company (Bard Access Systems, Inc.) | 2024 | — |
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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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 5…Class II Regulation Number: 880.5200 Premarket Notification Number: K162377 Bard Access Systems, Inc.’s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide ac… | 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 31 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 FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The PowerGlide ProTm Midline Catheter is inserted into a patient's vascular system for short-term use (< 30 days) to
sample blood or administer fluids intravenously. These catheters may be used for adult and pediatric patients, with
consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide ProTM
Midline Catheter is suitable for use with power injectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240359: PowerGlide Pro™ Midline Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240359
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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