510(k) Report

510(k) · Decided

Decided

PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)

K121383510(k) TraditionalDecided Sep 5, 2012120-day reviewClass II21 CFR 876.5630

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

Medical Components, Inc. · FJS Catheter, Peritoneal, Long-Term Indwelling

Cleared on Sep 5, 2012 as substantially equivalent to K071167 (Medigroup, Inc., 2007) and 4 other predicates after a 120-day review. Its family tree reaches back 10 generations to 2000. 2 of the 55 devices in its family, counting itself, have a Class I recall.

Decided
Sep 5, 2012
Review
120 days
Class
Class II
Product code
FJS
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K001901 (2000). 54 ancestors in all, the oldest K823331 (1983). No later device cites it as a predicate yet. 2 of the 55 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2011: 1 other ancestor2007: 2 other ancestors1995: 1 other ancestor1994: 2 other ancestors2003: 2 other ancestors2001: 4 other ancestors1999: 2 other ancestors1997: 1 other ancestor1996: 2 other ancestors1989: 5 other ancestors1983: 2 other ancestors2008: 1 other ancestor2006: 3 other ancestors1991: 2 other ancestors1987: 2 other ancestors2005: 5 other ancestors2004: 2 other ancestors2000: 3 other ancestors, 1 with a Class I recall11986: 2 other ancestors, 1 with a Class I recall1K001901 · 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×3: 3 generations cleared close together, K050185 (2005), K051417 (2005), K051991 (2005) K070996 · 4 FR Single Lumen (SL) Powerpicc Catheter · C.R. Bard, Inc. · 2007K091953 · Pro-Picc · Medcomp · 2009K113487 · Hemo-Cath 10F, Hemo-Cath 12.5F · Medical Components, Inc. · 20121980198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 8 other ancestors3 generations back: 6 other ancestors4 generations back: 4 other ancestors5 generations back: 7 other ancestors6 generations back: 9 other ancestors, 1 with a Class I recall17 generations back: 6 other ancestors, 1 with a Class I recall1 K113487 · Hemo-Cath 10F, Hemo-Cath 12.5F · Medical Components, Inc. · 2012K091953 · Pro-Picc · Medcomp · 2009K070996 · 4 FR Single Lumen (SL) Powerpicc Catheter · C.R. Bard, Inc. · 2007K051991 · Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line · C.R. Bard, Inc. · 2005K051417 · 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−10−50
  1. Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 6 generations between
  3. 3 generations backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
  4. 2 generations backK091953 Pro-PiccMedcomp · 2009
  5. 1 generation backK113487 Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012
  6. This deviceK121383 PS X Series (Basic Components and Catheter), PD X Series (Catheter…Medical Components, Inc. · 2012
Show all 10 generations
  1. Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 7 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
  5. 6 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
  6. 5 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
  7. 4 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  8. 3 generations backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
  9. 2 generations backK091953 Pro-PiccMedcomp · 2009
  10. 1 generation backK113487 Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012
  11. This deviceK121383 PS X Series (Basic Components and Catheter), PD X Series (Catheter…Medical Components, Inc. · 2012

Class I recalls in this family

  • K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…6 generations back · 2000
  • K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip7 generations back · 1986
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−9K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−8K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−7K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20041
−6K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005—
−5K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051
−4K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005—
−3K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc.2007—
−2K091953Pro-PiccMedcomp2009—
−1K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.2012—
0 (this device)K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All…Medical Components, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198320
198621
198720
198950
199120
199420
199510
199620
199710
199920
200031
200140
200320
200420
200550
200630
200720
200810
201110
FIG. 1 — Lineage of K121383, 2000–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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 FJS device

  1. #1 K213602 Argyle Peritoneal Dialysis Cathetor and Kit…score 3.0 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (5)

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
*K071167Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560
Summary page 1
…er & Accessories C.F.R. Section: 876.5630 Classification Panel: Gastroenterology and Urology Class: 11,78 FJS Predicate Devices: Primary: K071167, Flex-Neck® ExxTended m PID Catheter & Accessories, concurrence date August 31, 2007. Class 11CER §876.5630…
Medigroup, Inc.2007—
*K950042Swan Neck Presternal Peritoneal Dialysis Catheter
Summary page 1
…S Predicate Devices: Primary: K071167, Flex-Neck® ExxTended m PID Catheter & Accessories, concurrence date August 31, 2007. Class 11CER §876.5630 K950042, Swan Neck Prestemnal Peritoneal Dialysis Catheter, concurrence date December 15, 1995. Class 11CFR §876.5630…
Accurate Surgical Instruments Co.1995—
*K915490Medcomp Peritoneal Dialysis Catheters
Summary page 1
…ss 11CER §876.5630 K950042, Swan Neck Prestemnal Peritoneal Dialysis Catheter, concurrence date December 15, 1995. Class 11CFR §876.5630 K91 5490, Peritoneal Dialysis Catheter, concurrence date February 2, 1994. Class 11 CER §576.5630 Secondary: K113487: Hemo-Cath…
Medical Components, Inc.1994—
*K113487Hemo-Cath 10F, Hemo-Cath 12.5F
Summary page 1
…cember 15, 1995. Class 11CFR §876.5630 K91 5490, Peritoneal Dialysis Catheter, concurrence date February 2, 1994. Class 11 CER §576.5630 Secondary: K113487: Hemo-Cath K1 10424: CT Power Injectable implantable Infusion Port Device Description: The "X' Series PID Catheter i…
Medical Components, Inc.2012—
*K110424Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile…
Summary page 1
…76.5630 K91 5490, Peritoneal Dialysis Catheter, concurrence date February 2, 1994. Class 11 CER §576.5630 Secondary: K113487: Hemo-Cath K1 10424: CT Power Injectable implantable Infusion Port Device Description: The "X' Series PID Catheter is comprised of a silicone rubber…
Medcomp ( Medical Components)2011—

Also cleared against K071167: 1 other device →

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 · 6 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 · 7 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • 25 of the 54 ancestors have a recall of any class; 2 have a Class I recall.
  • 1 other device also cites its predicate K071167.

How does its category compare?

All FJS devices

FJS Catheter, Peritoneal, Long-Term Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FJS

1in 2022

2007: 22012: 32013: 12018: 12022: 1
2007high 3 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FJS

120in 2012

2012: 120 days median
2007high 120 (2012)2026

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

Recalls per year · FJS

1in 2014

2011: 42014: 1
2007high 4 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FJS

140in 2025

2007: 122008: 92009: 752010: 672011: 582012: 372013: 842014: 662015: 612016: 382017: 752018: 1372019: 532020: 942021: 782022: 1022023: 6192024: 1492025: 140
2007high 619 (2023) · low 9 (2008)2025

MAUDE reports naming product code FJS, 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
20072—012
20080—09
20090—075
20100—067
20110—458
20123120037
20131—084
20140—166
20150—061
20160—038
20170—075
20181—0137
20190—053
20200—094
20210—078
20221—0102
20230—0619
20240—0149
20250—0140
20260—0—

What is it indicated for?

The 'X' Series Catheter is indicated for chronic peritoneal dialysis.

The extended length of the 'X' Series Catheter makes it especially applicable for peritoneal dialysis patients when it is necessary to locate the skin exit site remote from the usual lower abdominal region. The catheter may be particularly indicated in patients with obesity, floppy abdominal skin folds, urinary or fecal incontinence, chronic yeast intertrigo, intestinal stomas, or in patients who desire to take deep tub baths.

Indications for use as stated in the FDA summary.

Also cleared against K071167

1 other device cites the same predicate.

  • K180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits…Covidien, LLC · 2018

More from Medical Components, Inc.

64 FDA decisions under this applicant name. See the company

  • K260080Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL TunnelerMedical Components, Inc. · 2026
  • K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc. · 2025
  • K141633Pro-Picc with Valve TechnologyMedical Components, Inc. · 2014
  • K132880Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014
  • K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc. · 2013

Recent decisions in FJS

The FJS category page

  • K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitCovidien, LLC · 2022
  • K180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits…Covidien, LLC · 2018
  • K130441Faller StyletMedionics International, Inc. · 2013
  • K120130Faller TrocarMedigroup, Inc. · 2012
  • K113354Veta Peritoneal Dialysis CatheterPfm Medical, Inc. · 20121 recall

https://510kreport.com/device/K121383 · printed Nov 5, 2026

Cite this page

510(k) Report. “K121383: PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121383

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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