510(k) · Cleared
Recalled · Class II · 2014Powerglide 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 Jun 1, 2012 as substantially equivalent to K112347 (Vascular Pathways, Inc., 2011) and 2 other predicates after a 53-day review. Its family tree reaches back 6 generations to 1993. 19 later devices descend from it. It has been recalled once.
- Decided
- Jun 1, 2012
- Review
- 53 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K932323 (1993). 21 ancestors in all, the oldest K801941 (1980). 19 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 5 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 4 generations backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- 3 generations backK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
- 2 generations backK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- 1 generation backK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- This deviceK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012
- Descendant · cites it directly · 12 of its ownK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 5 of its ownK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK150407 BioFlo Midline CatheterNavilyst Medical, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK162377 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK203069 HydroMIDAccess Vascular, Inc. · 2021 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K133856Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · cites it directly12descendants
- K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016 · 2 generations on5descendants
- K150407BioFlo Midline CatheterNavilyst Medical, Inc. · 2015 · 2 generations on5descendants
- K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016 · 3 generations on4descendants
- K203069HydroMIDAccess Vascular, Inc. · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −5 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −4 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| −3 | K090372 | The Wand Microaccess Safety Introducer | Access Scientific, Inc. | 2009 | — |
| −2 | K093022 | The Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| −1 | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| 0 (this device) | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | — |
| +1 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| +2 | K153280 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| +2 | K150407 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2015 | — |
| +3 | K162377 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| +3 | K203069 | HydroMID | Access Vascular, Inc. | 2021 | 3 |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K112347 | Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 GaugeSummary page 1…Predicate Trade Name: Rapid Intravascular Catheter Start System Classification Name: Intravascular Catheter Premarket Notification: K112347 Manufacturer: Vascular Pathways, Inc. Predicate Trade Name: PowerWand Safety Introdu… | 2011 |
| * | K101422 | The Power Wand Safety Introducer with an Extended Dwell CatheterSummary page 1…Predcatewith an Extended Dwell Catheter Predicae Classification Name: Catheter Introducer Premarket Notification: K101422 Manufacturer: Access Scientific, Inc. Predicate Trade Name: BD Nexiva Closed I… | 2011 |
| * | K102520 | BD Nexiva Closed IV Catheter SystemSummary page 1…te Trade Name: BD Nexiva Closed IV Catheter System Classification Name: Intravascular Catheter Premarket Notification: K102520 Manufacturer: Becton Dickinson, Inc.… | 2011 |
What descends from it? (19)
See all 195 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2014 | Class II | Z-1274-2015 | Nonconforming Material/Component | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 21 ancestors have a recall of any class.
- Of its descendants, K133856 (C.R. Bard, Inc., 2014) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K112347.
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. 2012, 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 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 Midline Catheter is suitable for use with power injectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121073: Powerglide 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/K121073
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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