510(k) · Cleared
ClearedHydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Access Vascular, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Aug 1, 2025 as substantially equivalent to K193015 (Access Vascular, Inc., 2020) and 2 other predicates after a 266-day review. Its family tree reaches back 13 generations to 2000. 2 of the 72 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 1, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K001901 (2000). 71 ancestors in all, the oldest K801941 (1980). No later device cites it as a predicate yet. 2 of the 72 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations between
- 3 generations backK172885 HydroPICCAccess Vascular, Inc. · 2018
- 2 generations backK193015 HydroPICC (PICC-142)Access Vascular, Inc. · 2020 · Recalled
- 1 generation backK213550 HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc. · 2022 · Recalled
- This deviceK243458 HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic…Access Vascular, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 12 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 11 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 10 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 9 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 8 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 7 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 6 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 5 generations backK101326 NMI ICNavilyst Medical, Inc. · 2010
- 4 generations backK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
- 3 generations backK172885 HydroPICCAccess Vascular, Inc. · 2018
- 2 generations backK193015 HydroPICC (PICC-142)Access Vascular, Inc. · 2020 · Recalled
- 1 generation backK213550 HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc. · 2022 · Recalled
- This deviceK243458 HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic…Access Vascular, Inc. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −12 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −11 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −10 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −9 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −8 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −7 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −6 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −5 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| −4 | K121089 | Nmi Picc Iii | Navilyst Medical, Inc. | 2012 | — |
| −3 | K172885 | HydroPICC | Access Vascular, Inc. | 2018 | — |
| −2 | K193015 | HydroPICC (PICC-142) | Access Vascular, Inc. | 2020 | 4 |
| −1 | K213550 | HydroPICC 5F Dual Lumen Catheter | Access Vascular, Inc. | 2022 | 2 |
| 0 (this device) | K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit… | Access Vascular, Inc. | 2025 | — |
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 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 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 |
|---|---|---|---|
| * | K193015 | HydroPICC (PICC-142)Summary page 7…e: LJS, FOZ Class: II Device Panel: General Hospital Predicate Device(s) The predicate devices are the HydroPICC (K193015), HydroPICC-251 Dual Lumen (K213550), and HydroMID Catheters (K220772). Device Description The HydroMID catheters are a family… | 2020 |
| * | K213550 | HydroPICC 5F Dual Lumen CatheterSummary page 7…II Device Panel: General Hospital Predicate Device(s) The predicate devices are the HydroPICC (K193015), HydroPICC-251 Dual Lumen (K213550), and HydroMID Catheters (K220772). Device Description The HydroMID catheters are a family of midline catheters comprised of a… | 2022 |
| * | K220772 | HydroMID 4F Single Lumen Midline CatheterSummary page 7…nel: General Hospital Predicate Device(s) The predicate devices are the HydroPICC (K193015), HydroPICC-251 Dual Lumen (K213550), and HydroMID Catheters (K220772). Device Description The HydroMID catheters are a family of midline catheters comprised of a radiopaque, hydrophilic catheter w… | 2022 |
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 · 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 25 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 27 of the 71 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K193015.
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
HydroPICC Single Lumen: Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0 ml/s HydroPICC Dual Lumen: Indicated for short- or long-term peripheral access to the central…
Read the full statement (240 words)
HydroPICC Single Lumen: Indicated for short-or long-term peripheral access to the central venous
system for intravenous therapy, including but not limited to the administration of fluids, medications,
and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of
contrast media. Rated for maximum power injection flow rate of 5.0 ml/s
HydroPICC Dual Lumen: Indicated for short- or long-term peripheral access to the central venous
system for intravenous therapy, including but not limited to the administration of fluids, medications,
and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of
contrast media. Rated for a maximum power injection flow rate of 5.0 ml/s
HydroMID Single Lumen: Indicated for short term access(< 30 days) to the peripheral venous
access system for intravenous therapy, including but not limited to, the administration of fluids,
medications, and the sampling of blood and blood products. Maximum Power Injection Flow Rate:
4Fr Single Lumen, 20cm: 6 ml/sec
The Hydro Catheter lines incorporate MIMIX® Technology, an anti-thrombogenic bulk hydrogel
material, designed to minimize the risk of thrombus formation on device surfaces. In vitro studies
have demonstrated that both the external surfaces and internal fluid pathw ays of the catheter
effectively reduce thrombus accumulation and thrombotic occlusions. This reduction in thrombus
accumulation is achieved due to the catheter's steric barrier. The clinical impact has not been
evaluated in human clinical trials. This device is not intended for the treatment of existing vein
thrombosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243458 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243458: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243458
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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