510(k) · Cleared
Recalled · Class I · 2026Arrow Pressure Injectable Midline Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, LLC Subsidiary of Teleflex Incorporated · PND Midline Catheter
Cleared on Sep 2, 2022 as substantially equivalent to K161313 (Arrow International, Inc. (Subsidiary of Teleflex, Inc.), 2016) after a 266-day review. Its family tree reaches back 11 generations to 2000. 4 of the 31 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Sep 2, 2022
- Review
- 266 days
- Class
- Class II
- Product code
- PND
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001901 (2000). 30 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 4 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations between
- 3 generations backK100635 Arrowgard Evolution Antimicrobial Peripherally Inserted Central…Arrow Intl., Inc. · 2010
- 2 generations backK112896 Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · Recalled (Class I)
- 1 generation backK161313 ARROW Pressure Injectable Midline Catheter with Chlorag+ard…Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · Recalled
- This deviceK213855 Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated · 2022
Show all 11 generations
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 9 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 8 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 6 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 5 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 4 generations backK080604 Pressure Injfectable PiccArrow International, Inc. · 2008 · Recalled
- 3 generations backK100635 Arrowgard Evolution Antimicrobial Peripherally Inserted Central…Arrow Intl., Inc. · 2010
- 2 generations backK112896 Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · Recalled (Class I)
- 1 generation backK161313 ARROW Pressure Injectable Midline Catheter with Chlorag+ard…Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · Recalled
- This deviceK213855 Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −10 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −9 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −8 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −6 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −5 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −4 | K080604 | Pressure Injfectable Picc | Arrow International, Inc. | 2008 | 1 |
| −3 | K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter… | Arrow Intl., Inc. | 2010 | — |
| −2 | K112896 | Arrw Evolution | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | Class I |
| −1 | K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and… | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016 | 2 |
| 0 (this device) | K213855 | Arrow Pressure Injectable Midline Catheter | Arrow International, LLC Subsidiary of Teleflex Incorporated | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 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.
4 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 PND device
- #1 K252402 Midline Catheterscore 13.2 · 10 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 |
|---|---|---|---|
| * | K161313 | ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…Summary page 4…heter Classification Name: Intravascular catheter Regulation: 21 CFR 880.5200 Product Code: PND Class: II 3. Predicate Devices K161313: Arrow Pressure Injectable Midline Catheter with ArrowG+ard Blue Advance Antimicrobial and Antithrombogenic Technology 4. Pu… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2387-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
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.
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 7 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 · 8 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 16 of the 30 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All PND devicesPND Midline Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PND
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PND
134in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PND
4so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · PND
141in 2025
MAUDE reports naming product code PND, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 3 | 106 | 0 | 5 |
| 2017 | 3 | 134 | 0 | 23 |
| 2018 | 2 | — | 0 | 19 |
| 2019 | 1 | — | 1 | 59 |
| 2020 | 0 | — | 2 | 93 |
| 2021 | 1 | — | 0 | 86 |
| 2022 | 2 | — | 1 | 178 |
| 2023 | 0 | — | 0 | 138 |
| 2024 | 0 | — | 0 | 168 |
| 2025 | 1 | — | 0 | 141 |
| 2026 | 0 | — | 4 (1) | — |
What is it indicated for?
The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (< 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
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/K213855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213855: Arrow Pressure Injectable 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/K213855
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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