510(k) Report

FDA product code · Gastroenterology and urology

Hemodialysis Catheter Luer End Cap

PEHClass II21 CFR 876.5540510(k) required2 decisions since 20130 recalls

2 FDA decisions since 2013. No recall names this code. The most-cited predicate is K131060, named by 1 later device.

For use in hemodialysis catheters to reduce hub infection.

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

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of PEH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PEH

1in 2018

2013: 12018: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PEH

Too few PEH 510(k)s in any year since 2007 to give a median.

Recalls per year · PEH

No recall names PEH since 2007.

Adverse event reports per year · PEH

2in 2020

2019: 72020: 2
2007high 7 (2019) · low 0 (2007)2025

MAUDE reports naming product code PEH, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20181—00
20190—07
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PEH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PEH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PEH devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K131060Clearguard HD End CapPursuit Vascular, Inc. · 20131cites it

Which PEH devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K180111ClearGuard HD Antimicrobial Barrier CapPursuit Vascular, Inc. · 20181generation

What has FDA decided in PEH lately?

  • K180111ClearGuard HD Antimicrobial Barrier CapPursuit Vascular, Inc. · 2018
  • K131060Clearguard HD End CapPursuit Vascular, Inc. · 2013

All 2 PEH decisions →

Related product codes

Other codes under 21 CFR 876.5540.

NFK Kit, Repair, Catheter, HemodialysisFJO Plier, TubeNNE Needle, Fistula, ReprocessedMSD Catheter, Hemodialysis, ImplantedLFJ Catheter, SubclavianFJY Plier, CrimpFKA Dilator, VesselNOO Clamp, Dialysis ArmNYU Catheter, Hemodialysis, Implanted, CoatedKNR Adapter, A-V Shunt Or FistulaMPB Catheter, Hemodialysis, Non-ImplantedPFH Venous Window Needle Guide