Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bedfont Scientific, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
391 daysmedian FDA review time
546 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211918 | iCOquit® Smokerlyzer® | Bedfont Scientific, Ltd. | 2021-12-21 | 183 | 0 |
| K203695 | NObreath® | Bedfont Scientific, Ltd. | 2021-12-17 | 364 | 0 |
| K173238 | ToxCO | Bedfont Scientific, Ltd. | 2019-04-04 | 546 | 0 |
| K082315 | EC50 MICRO+ SMOKERLYZER | Bedfont Scientific, Ltd. | 2010-02-01 | 537 | 0 |
| K070259 | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | Bedfont Scientific, Ltd. | 2008-02-21 | 391 | 0 |
| K000962 | PICO SMOKERLYZER, MODEL EC-50 | Bedfont Scientific, Ltd. | 2000-04-20 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda