510(k) · Cleared
ClearedM/29TM - Pressure Injectable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexicath, Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jul 11, 2012 as substantially equivalent to K080793 (Flexicath, Ltd., 2008) and 2 other predicates after a 369-day review. Its family tree reaches back 9 generations to 2000. 2 of the 36 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 11, 2012
- Review
- 369 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K001901 (2000). 35 ancestors in all, the oldest K823553 (1983). No later device cites it as a predicate yet. 2 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK080604 Pressure Injfectable PiccArrow International, Inc. · 2008 · Recalled
- 1 generation backK100635 Arrowgard Evolution Antimicrobial Peripherally Inserted Central…Arrow Intl., Inc. · 2010
- This deviceK111939 M/29TM - Pressure InjectableFlexicath, Ltd. · 2012
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 4 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK080604 Pressure Injfectable PiccArrow International, Inc. · 2008 · Recalled
- 1 generation backK100635 Arrowgard Evolution Antimicrobial Peripherally Inserted Central…Arrow Intl., Inc. · 2010
- This deviceK111939 M/29TM - Pressure InjectableFlexicath, Ltd. · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −4 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −3 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −2 | K080604 | Pressure Injfectable Picc | Arrow International, Inc. | 2008 | 1 |
| −1 | K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter… | Arrow Intl., Inc. | 2010 | — |
| 0 (this device) | K111939 | M/29TM - Pressure Injectable | Flexicath, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 2 | 0 |
| 1986 | 1 | 1 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 1 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K080793 | FirmgripSummary page 2…Page I of 3 Predicate Devices: 1) Flexicath'sFirmGripTM PeripherallyInserted Catheter Device, cleared under 5 10(k) number: K080793 and;- 2) Flexicath's FirmsGripTM PeripherallyInserted CathPeterDevice with the SNM (Safety Needle Mechanism) feature,… | 2008 |
| * | K092629 | SNM FirmgripSummary page 2…r: K080793 and;- 2) Flexicath's FirmsGripTM PeripherallyInserted CathPeterDevice with the SNM (Safety Needle Mechanism) feature, cleared under 5 10(k) number: K092629 and;- 3) Arrow's Antimicrobial Pressure Injectable P1CC, cleared under 5 10(k) number: K100635. Device description:… | 2009 |
| * | K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model…Summary page 2…Needle Mechanism) feature, cleared under 5 10(k) number: K092629 and;- 3) Arrow's Antimicrobial Pressure Injectable P1CC, cleared under 5 10(k) number: K100635. Device description: Flexicath's M/29r Pressure Injectable device is actually the very same device cleared under K(0807… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 6 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 35 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K080793.
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 Pressure Injectable M/29TM is a Peripherally Inserted Catheter Device which is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling and pressure injection applications such as contrast media injection.
The maximum flow rate for Flexicath Pressure Injectable midline catheter may not exceed 5ml/sec.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111939: M/29TM - Pressure Injectable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111939
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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