510(k) Report

510(k) · Cleared

Cleared

PD Cath

K053123510(k) TraditionalCleared Mar 29, 2006142-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

Med-Conduit, Inc. · FJS Catheter, Peritoneal, Long-Term Indwelling

Cleared on Mar 29, 2006 as substantially equivalent to K894131 (Thermedics, Inc., 1989) and 1 other predicate after a 142-day review. Its family tree reaches back 1 generation to 1987.

Decided
Mar 29, 2006
Review
142 days
Class
Class II
Product code
FJS
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K874650 (1987). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1989: 1 other ancestorK874650 · Peritoneal Dialysis Kit (Acute and Chronic Form) · Quinton, Inc. · 198719851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K874650 · Peritoneal Dialysis Kit (Acute and Chronic Form) · Quinton, Inc. · 19870
  1. Root · 1 generation backK874650 Peritoneal Dialysis Kit (Acute and Chronic Form)Quinton, Inc. · 1987
  2. This deviceK053123 PD CathMed-Conduit, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K874650Peritoneal Dialysis Kit (Acute and Chronic Form)Quinton, Inc.1987—
0 (this device)K053123PD CathMed-Conduit, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
FIG. 1 — Lineage of K053123, 1987–2006Source: 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.

Planning a device in FJS? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K894131Dermaport Vascular Access Device Model NO. 50-1000
Summary page 1
…n/Usual Name: Skin Port Catheter Classification Name: Long-Term PD Catheter Classification: 3. PREDICATE DEVICES Dermaport TM Access Device--K894131 Missouri Catheter-K874650 4. DEVICE DESCRIPTION The PD Cath is a radiopaque silicone, single lumen catheter used to…
Thermedics, Inc.1989—
*K874650Peritoneal Dialysis Kit (Acute and Chronic Form)
Summary page 1
…atheter Classification Name: Long-Term PD Catheter Classification: 3. PREDICATE DEVICES Dermaport TM Access Device--K894131 Missouri Catheter-K874650 4. DEVICE DESCRIPTION The PD Cath is a radiopaque silicone, single lumen catheter used to insert and remove periton…
Quinton, Inc.1987—

Also cleared against K894131: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K894131.

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.

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 PD Cath is indicated for use in attaining long term peritoneal access for peritoneal dialysis. The catheter is intended for implantation dwell time of greater than 30 days.

Indications for use as stated in the FDA summary.

Also cleared against K894131

1 other device cites the same predicate.

  • K043292HemocathMed-Conduit, Inc. · 2005

More from Med-Conduit, Inc.

3 FDA decisions under this applicant name. See the company

  • K062901Hemocath IIMed-Conduit, Inc. · 2007
  • K043292HemocathMed-Conduit, Inc. · 2005

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
  • K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc. · 2012
  • K120130Faller TrocarMedigroup, Inc. · 2012

https://510kreport.com/device/K053123 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053123: PD Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053123

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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