510(k) · Cleared
ClearedPowerGlide Pro Midline Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Sep 22, 2016 as substantially equivalent to K153280 (C.R. Bard, Inc., 2016) after a 29-day review. Its family tree reaches back 9 generations to 1993. 4 later devices descend from it.
- Decided
- Sep 22, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K932323 (1993). 24 ancestors in all, the oldest K801941 (1980). 4 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 5 generations between
- 3 generations backK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- 2 generations backK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- 1 generation backK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- This deviceK162377 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK252402 Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240359 PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, Inc.) · 2024
- Descendant · cites it directly · 0 of its ownK210047 Stiletto Extended Dwell CatheterPiper Access, LLC · 2021
- Descendant · cites it directly · 0 of its ownK170158 PowerGlide ST Midline CatheterC.R. Bard, Inc. · 2017 · Recalled
Show all 9 generations
- Root · 9 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 8 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 7 generations backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- 6 generations backK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
- 5 generations backK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- 4 generations backK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- 3 generations backK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- 2 generations backK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- 1 generation backK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- This deviceK162377 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K252402Midline CatheterTerumo Medical Products (Hangzhou) Co., Ltd. · 2025 · cites it directly0descendants
- K240359PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, Inc.) · 2024 · cites it directly0descendants
- K210047Stiletto Extended Dwell CatheterPiper Access, LLC · 2021 · cites it directly0descendants
- K170158PowerGlide ST Midline CatheterC.R. Bard, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −8 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −7 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| −6 | K090372 | The Wand Microaccess Safety Introducer | Access Scientific, Inc. | 2009 | — |
| −5 | K093022 | The Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| −4 | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| −3 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| −2 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| −1 | K153280 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| 0 (this device) | K162377 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| +1 | K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025 | — |
| +1 | K240359 | PowerGlide Pro™ Midline Catheter | Becton, Dickinson and Company (Bard Access Systems, Inc.) | 2024 | — |
| +1 | K210047 | Stiletto Extended Dwell Catheter | Piper Access, LLC | 2021 | — |
| +1 | K170158 | PowerGlide ST Midline Catheter | C.R. Bard, Inc. | 2017 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K153280 | PowerGlide Pro Midline CatheterSummary page 4…Classification Panel: General Hospital Predicate Trade Name: PowerGlide Pro™ Midline Catheter Premarket Notification: K153280 (cleared June 2, 2016) Manufacturer: Bard Access Systems, Inc. Common Name:… | 2016 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 24 ancestors have a recall of any class.
- Of its descendants, K252402 (Terumo Medical Products (Hangzhou) Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
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. 2016, 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 Pro 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 any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro Midline Catheter is suitable for use with power injectors.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162377 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162377: PowerGlide Pro Midline Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162377
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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