510(k) · Cleared
ClearedSynergy CT 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 Aug 19, 2010 as substantially equivalent to K083873 (Pfm Medical, Inc., 2009) and 3 other predicates after a 99-day review. Its family tree reaches back 10 generations to 2000. 2 of the 39 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Aug 19, 2010
- Review
- 99 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K001901 (2000). 32 ancestors in all, the oldest K830256 (1983). 6 later devices descend from it, 4 citing it directly. 2 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK062579 Omnipicc P.I.Rita Medical Systems, Inc. · 2006
- 2 generations backK071875 V-Cath Poly PiccHdc Corp. · 2007
- 1 generation backK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
- This deviceK101329 Synergy CT PiccHealth Line International Corporation · 2010
- Descendant · cites it directly · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013
- Descendant · cites it directly · 1 of its ownK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
- Descendant · cites it directly · 1 of its ownK113622 Orion II CT CVCHealth Line International Corporation (Hlic) · 2012
- Descendant · 2 generations on · 0 of its ownK200263 Health Line CT Midline CatheterHealth Line International Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK192533 Health Line CT CVCHealth Line International Corporation · 2019
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 5 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 4 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 3 generations backK062579 Omnipicc P.I.Rita Medical Systems, Inc. · 2006
- 2 generations backK071875 V-Cath Poly PiccHdc Corp. · 2007
- 1 generation backK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
- This deviceK101329 Synergy CT PiccHealth Line International Corporation · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K130034Uni-PiccHealth Line International Corporation · 2013 · cites it directly2descendants
- K140270Nexus Midline CT CatheterHealth Line International Corporation · 2014 · cites it directly1descendant
- K113622Orion II CT CVCHealth Line International Corporation (Hlic) · 2012 · cites it directly1descendant
- K200263Health Line CT Midline CatheterHealth Line International Corporation · 2020 · 2 generations on0descendants
- K192533Health Line CT CVCHealth Line International Corporation · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −5 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −4 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −3 | K062579 | Omnipicc P.I. | Rita Medical Systems, Inc. | 2006 | — |
| −2 | K071875 | V-Cath Poly Picc | Hdc Corp. | 2007 | — |
| −1 | K083873 | Picc (CT Rated and Non-Rated) | Pfm Medical, Inc. | 2009 | 3 |
| 0 (this device) | K101329 | Synergy CT Picc | Health Line International Corporation | 2010 | — |
| +1 | K130034 | Uni-Picc | Health Line International Corporation | 2013 | — |
| +1 | K140270 | Nexus Midline CT Catheter | Health Line International Corporation | 2014 | — |
| +1 | K113622 | Orion II CT CVC | Health Line International Corporation (Hlic) | 2012 | — |
| +2 | K200263 | Health Line CT Midline Catheter | Health Line International Corporation | 2020 | — |
| +2 | K192533 | Health Line CT CVC | Health Line International Corporation | 2019 | — |
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 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K083873 | Picc (CT Rated and Non-Rated)Summary page 4…device have the same technological characteristics, e.g. design, material, etc.? Yes. The PICC device of this submission, the SYNERGY'" CT PICC, is identical to that of (K083873), P/CC (CT Ratedoand Non-Rated). In fact, the SYNERGY' CT P1CC and the P1CC (CT Rated and Nan-Rated) are manufactured by the same… | 2009 |
| * | K051102 | Omnipicc PISummary page 2…Page 17 of 169 510(k) Premarlket Notification Submission: SYNERGY"' CT P1CC Proprietary Name: OmnIPICC P.d. (K051102) Regulation Name: Percutaneous, implanted, long-term intravascular catheter Common/Usual Name:… | 2005 |
| * | K062579 | Omnipicc P.I.Summary page 4…national Corporation, the submitter of this submission. In addition, the SYNERGY'" CT P/CC issubstantially equivalent to predicate devices, OmniPICC` PJ. (KO5i1102) and (K062579) and PRO-LINE CT Pressure Injectable CVC (K093309). The basic fundamental scientific technology of the device has not changed. Th… | 2006 |
| * | K093309 | Pro-Line CT (Basic Tray) Model MR28036101Summary page 2…Class II Product Code: us Regulation Number: 21 CFR 880.5970 Proprietary Name: PRO-LINE CT Pressure Injectable CVC (K093309) Regulation Name: Percutaneous, Implanted, Long-Term intravascular Catheter Common/Usual Name: Pe… | 2009 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 32 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K130034 (Health Line International Corporation, 2013) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K083873.
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. 2010, 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 SYNERGY' Tm CT P1CC is indicated for short or long term (less than or greater than 30
days) peripheral access to the central venous system for infusion, intravenous therapy,
blood sampling and power injection of contrast media. All SYNERGY'Tm CT P1CC products
have a maximum recommended infusion rating of Smi/sec.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101329: Synergy CT Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101329
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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