510(k) · Cleared
Recalled · Class II · 2014Picc (CT Rated and Non-Rated)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pfm Medical, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Mar 19, 2009 as substantially equivalent to K072391 (Pfm Medical, Inc., 2007) and 1 other predicate after an 80-day review. Its family tree reaches back 9 generations to 2000. 2 of the 35 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 19, 2009
- Review
- 80 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001901 (2000). 26 ancestors in all, the oldest K830256 (1983). 8 later devices descend from it, 2 citing it directly. 2 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK062579 Omnipicc P.I.Rita Medical Systems, Inc. · 2006
- 1 generation backK071875 V-Cath Poly PiccHdc Corp. · 2007
- This deviceK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK101329 Synergy CT PiccHealth Line International Corporation · 2010
- Descendant · 2 generations on · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
- Descendant · 2 generations on · 1 of its ownK113622 Orion II CT CVCHealth Line International Corporation (Hlic) · 2012
- Descendant · 3 generations on · 0 of its ownK200263 Health Line CT Midline CatheterHealth Line International Corporation · 2020
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 4 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK062579 Omnipicc P.I.Rita Medical Systems, Inc. · 2006
- 1 generation backK071875 V-Cath Poly PiccHdc Corp. · 2007
- This deviceK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K101329Synergy CT PiccHealth Line International Corporation · 2010 · cites it directly6descendants
- K130034Uni-PiccHealth Line International Corporation · 2013 · 2 generations on2descendants
- K140270Nexus Midline CT CatheterHealth Line International Corporation · 2014 · 2 generations on1descendant
- K113622Orion II CT CVCHealth Line International Corporation (Hlic) · 2012 · 2 generations on1descendant
- K200263Health Line CT Midline CatheterHealth Line International Corporation · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −4 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −3 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −2 | K062579 | Omnipicc P.I. | Rita Medical Systems, Inc. | 2006 | — |
| −1 | K071875 | V-Cath Poly Picc | Hdc Corp. | 2007 | — |
| 0 (this device) | K083873 | Picc (CT Rated and Non-Rated) | Pfm Medical, Inc. | 2009 | — |
| +1 | K101329 | Synergy CT Picc | Health Line International Corporation | 2010 | — |
| +2 | K130034 | Uni-Picc | Health Line International Corporation | 2013 | — |
| +2 | K140270 | Nexus Midline CT Catheter | Health Line International Corporation | 2014 | — |
| +2 | K113622 | Orion II CT CVC | Health Line International Corporation (Hlic) | 2012 | — |
| +3 | 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 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K072391 | PFM PiccSummary page 1…ar, Therapeutic, Long Term Classification: LJS Equivalent Devices: Manufacturer: PFM Medical Name: PFM PICC 510(k)#: K072391 Manufacturer: HDC Corporation Name: V-Cath Power PICC 510(k)#: K071875 Device Descr… | 2007 |
| * | K071875 | V-Cath Poly PiccSummary page 1…PFM PICC 510(k)#: K072391 Manufacturer: HDC Corporation Name: V-Cath Power PICC 510(k)#: K071875 Device Description: The PICC (CT Rated and Non-Rated) is a family of peripherally inserted central venous catheters designed to p… | 2007 |
What descends from it? (8)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2014 | Class II | Z-0563-2015 | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
| Oct 20, 2014 | Class II | Z-0565-2015 | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
| Oct 20, 2014 | Class II | Z-0564-2015 | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
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 · 5 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 · 6 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 11 of the 26 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K101329 (Health Line International Corporation, 2010) has gone furthest, with 6 descendants of its own.
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. 2009, 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 PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, and blood sampling.
The CT rated PICC is also indicated for the power injection of contrast media.
The CT rated PICC has a maximum recommended infusion rating of 5 ml/sec.
The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083873: Picc (CT Rated and Non-Rated).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083873
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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