Sequal Technologies, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sequal Technologies, Inc.” (first 2001, latest 2010), across 1 product code in 1 review panel. Median 510(k) review time under this name: 214 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | 6 | 6 |
Review panels
- Anesthesiology (6)
Most recent Sequal Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100920 | MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES | CAW | 2010-11-29 | 241 |
| K091541 | MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES | CAW | 2009-12-31 | 219 |
| K083163 | OMNI 2 OXYGEN SYSTEM | CAW | 2009-10-20 | 358 |
| K042262 | INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 | CAW | 2004-09-10 | 18 |
| K013931 | OMNI OXYGEN SYSTEM, MODEL 1000 | CAW | 2002-03-27 | 119 |
| K003472 | INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM | CAW | 2001-06-04 | 208 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-10-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sequal Technologies, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Sequal Technologies, Inc.” (first 2001, latest 2010), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sequal Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sequal Technologies, Inc. is 214 days.
Which FDA product codes appear under Sequal Technologies, Inc.?
The most frequent FDA product codes under this applicant name are CAW (Generator, Oxygen, Portable, 6).
Next steps
- See all 6 Sequal Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAW, Sequal Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.