510(k) Report

FDA applicant

Shiley Infusaid, Inc.

Norwood, MA3 decisions1987–19880 recalls

FDA records 3 decisions for Shiley Infusaid, Inc. (Norwood, MA) from 1987 to 1988: 3 510(k) clearances. All are in product code LJT (Port & Catheter, Implanted, Subcutaneous…). No recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Shiley Infusaid, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shiley Infusaid, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Shiley Infusaid, 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?

  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular3decisions

What has FDA decided for it lately?

  • K881745Infuse-a-Port Radiopaque Polyurethane CatheterShiley Infusaid, Inc. · 1988
  • K872329Infuse-a-Port Additional SizesShiley Infusaid, Inc. · 1987
  • K872898Polyurethane Catheter for the Infuse-a-PortShiley Infusaid, Inc. · 1987

All 3 as Shiley Infusaid, Inc. →

Other applicant names beginning “Shiley”

FDA records each applicant name separately; these may or may not be the same firm.

Shiley, Inc. 174