510(k) · Cleared
ClearedUni-Picc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Line International Corporation · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Mar 8, 2013 as substantially equivalent to K101329 (Health Line International Corporation, 2010) and 2 other predicates after a 60-day review. Its family tree reaches back 11 generations to 2000. 2 of the 42 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Mar 8, 2013
- Review
- 60 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K001901 (2000). 39 ancestors in all, the oldest K830256 (1983). 2 later devices descend from it, 1 citing it directly. 2 of the 42 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 backK071875 V-Cath Poly PiccHdc Corp. · 2007
- 2 generations backK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
- 1 generation backK101329 Synergy CT PiccHealth Line International Corporation · 2010
- This deviceK130034 Uni-PiccHealth Line International Corporation · 2013
- Descendant · cites it directly · 1 of its ownK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK200263 Health Line CT Midline CatheterHealth Line International Corporation · 2020
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 backK062579 Omnipicc P.I.Rita Medical Systems, Inc. · 2006
- 3 generations backK071875 V-Cath Poly PiccHdc Corp. · 2007
- 2 generations backK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
- 1 generation backK101329 Synergy CT PiccHealth Line International Corporation · 2010
- This deviceK130034 Uni-PiccHealth Line International Corporation · 2013
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView 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 | K062579 | Omnipicc P.I. | Rita Medical Systems, Inc. | 2006 | — |
| −3 | K071875 | V-Cath Poly Picc | Hdc Corp. | 2007 | — |
| −2 | K083873 | Picc (CT Rated and Non-Rated) | Pfm Medical, Inc. | 2009 | 3 |
| −1 | K101329 | Synergy CT Picc | Health Line International Corporation | 2010 | — |
| 0 (this device) | K130034 | Uni-Picc | Health Line International Corporation | 2013 | — |
| +1 | K140270 | Nexus Midline CT Catheter | Health Line International Corporation | 2014 | — |
| +2 | K200263 | Health Line CT Midline Catheter | Health Line International Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 1 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K101329 | Synergy CT PiccSummary page 3…te devices. Does the new device have the same indication statements? Yes, the first paragraph of the indications for use statement isthe same as the SYNERGYT m CT P1CC (K101329) with the exception of the removal of power injection. The last paragraph of the indications for use statement isthe same as the… | 2010 |
| * | K102966 | 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccSummary page 3…T m CT P1CC (K101329) with the exception of the removal of power injection. The last paragraph of the indications for use statement isthe same as the 2.6F Vascu-PICC® (1(102966) predicate with the exception of noting the 3F size. Do the differences alter the intended therapeutic/diagnostic/etc. effect (i… | 2010 |
| * | K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple LumenSummary page 2…21 CFR 880.5970 Proprietary Name: Vascu-PICCO and Midline Catheters, Single, Double and Triple Lumen (K091586) Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Common/Usual Name:… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140270 | Nexus Midline CT Catheter | 2014 | 1 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 39 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K140270 (Health Line International Corporation, 2014) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K101329.
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. 2013, 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?
The UNI-PICCm' Peripherally Inserted Central Catheter is indicated for short or long term access to the central venous system for intravenous administration of fluids, medications and/or nutritional therapy when prescribed. Blood sampling may also be conducted with UNI-PJCCmt
The 3F UNI-PICC m Peripherally inserted Central Catheter is indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants and children. It may be used for administration of fluids, medications and/or nutritional therapy when prescribed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130034: Uni-Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130034
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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