510(k) Report

FDA applicant

Ash Access Technology, Inc.

Lafayette, IN2 decisions2007–20093 recalls

FDA records 2 decisions for Ash Access Technology, Inc. (Lafayette, IN) from 2007 to 2009: 2 510(k) clearances. All are in product code MSD (Catheter, Hemodialysis, Implanted). Its devices cite 7 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Ash Access Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2008

2008: 3
2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ash Access Technology, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ash Access Technology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MSDCatheter, Hemodialysis, Implanted2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CMAsh Access Technology, Inc. · 20072cite it
  • K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc. · 20091cites it

What has FDA decided for it lately?

  • K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc. · 2009
  • K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM, 15FR X 32CMAsh Access Technology, Inc. · 20073 recalls

All 2 as Ash Access Technology, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K070572Centros (TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm From…Jul 7, 2008
  • K070572Centros (TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set (With Cuff 27cm From…Jul 7, 2008
  • K070572Centros (TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With Cuff 19cm From…Jul 7, 2008