510(k) · Cleared
ClearedAccucath Midline Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Pathways, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jan 8, 2015 as substantially equivalent to K121073 (C.R. Bard, Inc., 2012) and 1 other predicate after a 157-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Jan 8, 2015
- Review
- 157 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K932323 (1993). 32 ancestors in all, the oldest K801941 (1980). No later device cites it as a predicate yet.
- 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 deviceK142136 Accucath Midline Catheter SystemVascular Pathways, Inc. · 2015
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) | K142136 | Accucath Midline Catheter System | Vascular Pathways, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2014 | 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? (2)
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 4…OZ / 21 CFR § 880.5200 Classification Class 2 Predicate Devices Bard Access PowerGlide™ Device (K121073) Vascular Pathways, Inc., AccuCath® BC Intravascular Catheter System (K140504)… | 2012 |
| * | K140504 | Accucath BC Intravascular Catheter SystemSummary page 4…evices Bard Access PowerGlide™ Device (K121073) Vascular Pathways, Inc., AccuCath® BC Intravascular Catheter System (K140504) 45 Vascular Pathways, Inc.… | 2014 |
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 22 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 32 ancestors have a recall of any class.
- 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. 2015, 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 AccuCath® Midline Catheter System is a midline catheter that is inserted into a patient’s vascular system for short term use (< 30 days) to sample blood, monitor blood pressure, and administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath® Midline is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 7mL/second.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142136 · printed Nov 3, 2026
Cite this page
510(k) Report. “K142136: Accucath Midline Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K142136
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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