510(k) Report

FDA applicant

Catch, Inc.

Longview, WA2 decisions2001–20061 recall

FDA records 2 decisions for Catch, Inc. (Longview, WA) from 2001 to 2006: 2 510(k) clearances. All are in product code LPS (Urinary Homocystine (Nonquantitative) Test…). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Catch Incorporated”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Catch, Inc. since 2007.

Recalls per year

1in 2007

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

Class I Class II/III not classified

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

Planning a device like Catch, 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?

  • LPSUrinary Homocystine (Nonquantitative) Test System2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K011689Homogeneous Enzymic Homocysteine ReagentCatch, Inc. · 20011cites it
  • K062808Liquid Stable (LS) 2-Part Homocysteine ReagentCatch Incorporated · 20061cites it

What has FDA decided for it lately?

  • K062808Liquid Stable (LS) 2-Part Homocysteine ReagentCatch Incorporated · 2006
  • K011689Homogeneous Enzymic Homocysteine ReagentCatch, Inc. · 20011 recall

The one decision as Catch, Inc. →The one decision as Catch Incorporated →

What has been recalled?

1 recall linked to its devices; the latest:

  • K011689Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2…Jan 18, 2007