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 Jan 16, 2014 as substantially equivalent to K121073 (C.R. Bard, Inc., 2012) after a 28-day review. Its family tree reaches back 7 generations to 1993. 12 later devices descend from it. It has been recalled once.
- Decided
- Jan 16, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K932323 (1993). 22 ancestors in all, the oldest K801941 (1980). 12 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 6 generations backK990705 Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific…Medamicus, Inc. · 1999 · Recalled
- 5 generations backK071574 Stiffer Coaxial Micro-Introducer KitEnpath Medical, Inc. · 2007 · Recalled
- 4 generations backK090372 The Wand Microaccess Safety IntroducerAccess Scientific, Inc. · 2009
- 3 generations backK093022 The Picc Wand Peelable Safety IntroducerAccess Scientific, Inc. · 2010
- 2 generations backK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- 1 generation backK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- This deviceK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK150407 BioFlo Midline CatheterNavilyst Medical, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK162377 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK203069 HydroMIDAccess Vascular, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 2 of its ownK220772 HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016 · cites it directly5descendants
- K150407BioFlo Midline CatheterNavilyst Medical, Inc. · 2015 · cites it directly5descendants
- K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016 · 2 generations on4descendants
- K203069HydroMIDAccess Vascular, Inc. · 2021 · 2 generations on3descendants
- K220772HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −6 | K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator… | Medamicus, Inc. | 1999 | 1 |
| −5 | K071574 | Stiffer Coaxial Micro-Introducer Kit | Enpath Medical, Inc. | 2007 | 2 |
| −4 | K090372 | The Wand Microaccess Safety Introducer | Access Scientific, Inc. | 2009 | — |
| −3 | K093022 | The Picc Wand Peelable Safety Introducer | Access Scientific, Inc. | 2010 | — |
| −2 | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| −1 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| 0 (this device) | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | — |
| +1 | K153280 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| +1 | K150407 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2015 | — |
| +2 | K162377 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| +2 | K203069 | HydroMID | Access Vascular, Inc. | 2021 | 3 |
| +3 | K220772 | HydroMID 4F Single Lumen Midline Catheter | Access Vascular, Inc. | 2022 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 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? (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 |
|---|---|---|---|
| * | K121073 | Powerglide Midline CatheterSummary page 1…ate Trade Name: PowerGlide® Midline Catheter Predicate Classification Name: Intravascular Catheter Device Premarket Notification: K121073 Manufacturer: Bard Access Systems, Inc. Bard Access Systems, Inc.'s PowerGlid… | 2012 |
What descends from it? (12)
See all 122 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 21 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 22 ancestors have a recall of any class.
- Of its descendants, K153280 (C.R. Bard, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K121073.
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. 2014, 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/K133856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133856: 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/K133856
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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