Bedfont Scientific, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Bedfont Scientific, Ltd.” (first 2000, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 378 days. Since 2017 the median was 364 days, against 247 days for all cleared 510(k)s in the same product codes. 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 | 1 | 546 |
| 2020 | 0 | — |
| 2021 | 2 | 274 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bedfont Scientific, Ltd. took a median 364 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 247 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 5 | 5 |
| MXA | System, Test, Breath Nitric Oxide | 1 | 1 |
Review panels
- Anesthesiology (5)
- Clinical Chemistry (1)
Most recent Bedfont Scientific, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211918 | iCOquit® Smokerlyzer® | CCJ | 2021-12-21 | 183 |
| K203695 | NObreath® | MXA | 2021-12-17 | 364 |
| K173238 | ToxCO | CCJ | 2019-04-04 | 546 |
| K082315 | EC50 MICRO+ SMOKERLYZER | CCJ | 2010-02-01 | 537 |
| K070259 | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | CCJ | 2008-02-21 | 391 |
| K000962 | PICO SMOKERLYZER, MODEL EC-50 | CCJ | 2000-04-20 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Bedfont Scientific, Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bedfont Technical Instruments , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bedfont Scientific, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Bedfont Scientific, Ltd.” (first 2000, latest 2021), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bedfont Scientific, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bedfont Scientific, Ltd. is 378 days. Since 2017: 364 days, versus 247 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bedfont Scientific, Ltd.?
The most frequent FDA product codes under this applicant name are CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, 5); MXA (System, Test, Breath Nitric Oxide, 1).
Next steps
- See all 6 Bedfont Scientific, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CCJ, Bedfont Scientific, Ltd.'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.