510(k) · Cleared
ClearedNexus Midline CT Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Line International Corporation · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 20, 2014 as substantially equivalent to K101329 (Health Line International Corporation, 2010) and 3 other predicates after a 198-day review. Its family tree reaches back 12 generations to 2000. 2 of the 64 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Aug 20, 2014
- Review
- 198 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K001901 (2000). 62 ancestors in all, the oldest K801941 (1980). 1 later device descends from it, 1 citing it directly. 2 of the 64 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations between
- 3 generations backK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
- 2 generations backK101329 Synergy CT PiccHealth Line International Corporation · 2010
- 1 generation backK130034 Uni-PiccHealth Line International Corporation · 2013
- This deviceK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
- Descendant · cites it directly · 0 of its ownK200263 Health Line CT Midline CatheterHealth Line International Corporation · 2020
Show all 12 generations
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 11 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 10 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 9 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 8 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 7 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 6 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 5 generations backK062579 Omnipicc P.I.Rita Medical Systems, Inc. · 2006
- 4 generations backK071875 V-Cath Poly PiccHdc Corp. · 2007
- 3 generations backK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
- 2 generations backK101329 Synergy CT PiccHealth Line International Corporation · 2010
- 1 generation backK130034 Uni-PiccHealth Line International Corporation · 2013
- This deviceK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K200263Health Line CT Midline CatheterHealth Line International Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −11 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −10 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −9 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −8 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −7 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −6 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −5 | K062579 | Omnipicc P.I. | Rita Medical Systems, Inc. | 2006 | — |
| −4 | K071875 | V-Cath Poly Picc | Hdc Corp. | 2007 | — |
| −3 | K083873 | Picc (CT Rated and Non-Rated) | Pfm Medical, Inc. | 2009 | 3 |
| −2 | K101329 | Synergy CT Picc | Health Line International Corporation | 2010 | — |
| −1 | K130034 | Uni-Picc | Health Line International Corporation | 2013 | — |
| 0 (this device) | K140270 | Nexus Midline CT Catheter | Health Line International Corporation | 2014 | — |
| +1 | K200263 | Health Line CT Midline Catheter | Health Line International Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 1 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 1 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (4)
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 |
|---|---|---|---|
| * | K101329 | Synergy CT PiccSummary page 4…Class II Product Code: FOZ Regulation Number: 21 CFR 880.5200 PREDICATE DEVICES: Proprietary Name: SYNERGY™ CT PICC (K101329) Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Common/Usual Name: Peripher… | 2010 |
| * | K130034 | Uni-PiccSummary page 5…ry Class: Class II Product Code: LJS Regulation Number: 21 CFR 880.5970 Proprietary Name: UNI-PICC™ (K130034) Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Common/Usual Name: Peripherally… | 2013 |
| * | K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple LumenSummary page 5…gulation Number: 21 CFR 880.5970 Proprietary Name: Vascu-PICC® and Midline Catheters, Single, Double and Triple Lumen (K091586) Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Common/Usual Name: Catheter, In… | 2009 |
| * | K121073 | Powerglide Midline CatheterSummary page 5…atory Class: Class II Product Code: LJS Regulation Number: 21 CFR 880.5970 Proprietary Name: PowerGlide Midline Catheter (K121073) Regulation Name: Intravascular Catheter Common/Usual Name: Intravascular Catheter Classification Panel:… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200263 | Health Line CT Midline Catheter | 2020 | 0 |
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 · 4 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 · 5 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 22 of the 62 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K200263 (Health Line International Corporation, 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K101329.
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 NEXUS™ MIDLINE CT CATHETER is indicated for short term (less than 30 days) peripheral access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The NEXUS™ MIDLINE CT CATHETER is suitable for use with power injectors. For maximum flow rate and maximum pressure that can be used during power injection, please refer to the following: Catheter Size Priming Volume | Max Labeled Flow Rate (ml/sec)* Max Internal Catheter…
Read the full statement (185 words)
The NEXUS™ MIDLINE CT CATHETER is indicated for short term (less than 30 days) peripheral access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The NEXUS™ MIDLINE CT CATHETER is suitable for use with power injectors. For maximum flow rate and maximum pressure that can be used during power injection, please refer to the following:
Catheter Size Priming Volume | Max Labeled Flow Rate (ml/sec)* Max Internal Catheter Rated Burst Pressure at Max Flow Rate Pressure (psi) (psi)**
3Fr Single Lumen 0.29 1 167 251
4Fr Single Lumen 0.37 5 164 299
4Fr Dual Lumen 0.35/0.35 3 173/173 299
SFr Single Lumen 0.38 9 112 300
5 Fr Dual Lumen 0.37/0.37 5 179/179 299
* Pressurized flow rates are determined with pump safety cut-off at 300 psi using viscous fluid at 11.8 centipoise (cP) and represents approximate flow capability of power injection of contrast media.
** Max Burst Pressure is the static burst pressure failure point of the catheter when the lumen is completely occluded. WARNING: Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.
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/K140270 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140270: Nexus Midline CT Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140270
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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