510(k) Report

FDA applicant

Sequal Technologies, Inc.

San Diego, CA6 decisions2001–20102 recalls

FDA records 6 decisions for Sequal Technologies, Inc. (San Diego, CA) from 2001 to 2010: 6 510(k) clearances. All are in product code CAW (Generator, Oxygen, Portable). Its devices cite 10 predicates, 6 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Sequal Technologies Co., Ltd.”.

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

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2010

2009: 22010: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2009: 12019: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sequal Technologies, 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?

  • CAWGenerator, Oxygen, Portable6decisions

Whose devices does it build on?

Its devices cite 10 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 6 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.

  • K013931Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 200210cite it
  • K003472Integra Oxygen Concentrators Model 6400-OMSequal Technologies, Inc. · 20014cite it
  • K042262Integra Oxygen Concentrator, Model 6323A-OM-10Sequal Technologies, Inc. · 20043cite it
  • K083163Omni 2 Oxygen SystemSequal Technologies, Inc. · 20093cite it

What has FDA decided for it lately?

  • K100920Mesa II Oxygen Concentrator Model: T2000 SeriesSequal Technologies Co., Ltd. · 2010
  • K091541Mesa Oxygen Concentrator, Model 2-6000 SeriesSequal Technologies Co., Ltd. · 2009
  • K083163Omni 2 Oxygen SystemSequal Technologies, Inc. · 20091 recall
  • K042262Integra Oxygen Concentrator, Model 6323A-OM-10Sequal Technologies, Inc. · 2004
  • K013931Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 20021 recall
  • K003472Integra Oxygen Concentrators Model 6400-OMSequal Technologies, Inc. · 2001

All 4 as Sequal Technologies, Inc. →All 2 as Sequal Technologies Co., Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K083163SAROS Oxygen System Model 3000Sep 16, 2019Class II
  • K013931SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the…Oct 1, 2009