510(k) Report

FDA applicant

Ammed Surgical Equipment, LLC

Austin, TX1 decision2012–20121 recall

FDA records 1 decision for Ammed Surgical Equipment, LLC (Austin, TX) in 2012: 1 510(k) clearance. All are in product code KCT (Sterilization Wrap Containers, Trays…). 1 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 Ammed Surgical Equipment, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2012high 1 (2016) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Ammed Surgical Equipment, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ammed Surgical Equipment, LLC’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?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K110898S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC · 20122cite it

What has FDA decided for it lately?

  • K110898S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC · 20121 recall

The one decision as Ammed Surgical Equipment, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K110898The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)Jan 13, 2016Class II