510(k) Report

510(k) · Cleared

Cleared

PFM Picc

K072391510(k) TraditionalCleared Nov 19, 200787-day reviewClass II21 CFR 880.5970

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pfm Medical, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Nov 19, 2007 as substantially equivalent to K053345 (Medcomp, 2006) after an 87-day review. Its family tree reaches back 7 generations to 2000. 9 later devices descend from it.

Decided
Nov 19, 2007
Review
87 days
Class
Class II
Product code
LJS
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K001901 (2000). 9 ancestors in all, the oldest K830256 (1983). 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1983: 1 other ancestor2009: 1 descendant cleared2011: 1 descendant cleared2010: 1 descendant cleared2012: 2 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant clearedK001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalled×2: 2 generations cleared close together, K050185 (2005), K051417 (2005) K053345 · Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D · Medcomp · 2006 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K053345 · Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D · Medcomp · 2006 · recalledK051417 · 6 FR FL Powerhohn and Powerline Catheter · C.R. Bard, Inc. · 2005 · recalledK050185 · Powerhohn and Powerline Catheters · C.R. Bard, Inc. · 2005K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−50
  1. Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 4 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
  5. 3 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
  6. 2 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
  7. 1 generation backK053345 Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DMedcomp · 2006 · Recalled
  8. This deviceK072391 PFM PiccPfm Medical, Inc. · 2007
  9. Descendant · cites it directly · 8 of its ownK083873 Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · Recalled
  10. Descendant · 2 generations on · 6 of its ownK101329 Synergy CT PiccHealth Line International Corporation · 2010
  11. Descendant · 3 generations on · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013
  12. Descendant · 3 generations on · 1 of its ownK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
  13. Descendant · 3 generations on · 1 of its ownK113622 Orion II CT CVCHealth Line International Corporation (Hlic) · 2012

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 12012: 22013: 12014: 12019: 12020: 1
2009high 2 (2012) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all
  • K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc. · 2009 · cites it directly8descendants
  • K101329Synergy CT PiccHealth Line International Corporation · 2010 · 2 generations on6descendants
  • K130034Uni-PiccHealth Line International Corporation · 2013 · 3 generations on2descendants
  • K140270Nexus Midline CT CatheterHealth Line International Corporation · 2014 · 3 generations on1descendant
  • K113622Orion II CT CVCHealth Line International Corporation (Hlic) · 2012 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−6K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−5K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−4K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20041
−3K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005—
−2K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051
−1K053345Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DMedcomp20061
0 (this device)K072391PFM PiccPfm Medical, Inc.2007—
+1K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.20093
+2K101329Synergy CT PiccHealth Line International Corporation2010—
+3K130034Uni-PiccHealth Line International Corporation2013—
+3K140270Nexus Midline CT CatheterHealth Line International Corporation2014—
+3K113622Orion II CT CVCHealth Line International Corporation (Hlic)2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201110
201220
201310
201410
201910
202010
FIG. 1 — Lineage of K072391, 2000–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in LJS? 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. #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K053345Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D
Summary page 1
…Term Classification: UJS Equivalent Devices: Manufacturer: MedComp Name: PRO-LINE CT Power Injectable CVC 51 0(k)# K053345 Device Description: The PFM Medical PFM PICC Catheters are designed for central venous catheterization. The PFM PICC lumen is co…
Medcomp20061

Also cleared against K053345: 6 other devices →

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.20098

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 6 of the 9 ancestors have a recall of any class.
  • Of its descendants, K083873 (Pfm Medical, Inc., 2009) has gone furthest, with 8 descendants of its own.
  • 6 other devices also cite its predicate K053345.

How does its category compare?

All LJS devices

LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LJS

8in 2025

2007: 142008: 42009: 162010: 92011: 62012: 142013: 142014: 82015: 72016: 92017: 72018: 102020: 22021: 32022: 32023: 42024: 12025: 82026 (partial year): 2
2007high 16 (2009) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJS

171in 2025

2007: 92 days median2008: 97 days median2009: 70 days median2010: 114 days median2011: 55 days median2012: 77 days median2013: 31 days median2014: 47 days median2015: 71 days median2016: 128 days median2017: 101 days median2018: 148 days median2021: 284 days median2022: 177 days median2023: 47 days median2025: 171 days median
2007high 284 (2021) · low 31 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJS

5in 2023

2008: 12009: 12010: 122011: 42012: 402014: 152015: 22016: 182017: 92018: 32021: 12023: 5, 2 Class I2026 (partial year): 8, 1 Class I
2007high 40 (2012) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · LJS

4,372in 2025

2007: 3922008: 3692009: 3792010: 4952011: 6962012: 5642013: 6802014: 8422015: 1,3062016: 1,1232017: 2,1002018: 2,3242019: 2,0522020: 2,5392021: 3,0842022: 3,2562023: 2,7992024: 4,2432025: 4,372
2007high 4,372 (2025) · low 369 (2008)2025

MAUDE reports naming product code LJS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714920392
20084971369
200916701379
2010911412495
20116554696
2012147740564
201314310680
201484715842
201577121,306
20169128181,123
2017710192,100
20181014832,324
20190—02,052
20202—02,539
2021328413,084
2022317703,256
20234475 (2)2,799
20241—04,243
2025817104,372
20262—8 (1)—

What is it indicated for?

The PFM PICC is indicated for short or long term access to the central venous system. It is designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5 cc/sec. The maximum pressure of power injectors used with the PFM PICC may not exceed 300 psi.

Indications for use as stated in the FDA summary.

Also cleared against K053345

6 other devices cite the same predicate.

  • K110627Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd. · 2011
  • K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components) · 2009
  • K091953Pro-PiccMedcomp · 2009
  • K081904Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp · 20082 recalls
  • K072509Pro-Picc, Basic Tray; Long Wire Tray; Basic Nursing Tray; Full Nursing TrayMedcomp · 2007
  • K071361R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001, 002,004,005R4 Vascular, Inc. · 2007

More from Pfm Medical, Inc.

25 FDA decisions under this applicant name. See the company

  • K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc. · 2025
  • K241278ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc. · 2025
  • P120009/S004Nit-Occlud PdaPfm Medical, Inc. · 2024
  • K221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc. · 2023
  • K213666NuCath Wedge Pressure CatheterPfm Medical, Inc. · 2022

Recent decisions in LJS

The LJS category page

  • K260080Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL TunnelerMedical Components, Inc. · 2026
  • K260929Neonav ECG Tip Location SystemNavi Medical Technologies · 2026
  • K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and…Spectrum Vascular · 2025
  • K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc. · 2025
  • K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single…Access Vascular, Inc. · 2025

https://510kreport.com/device/K072391 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072391: PFM Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072391

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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