Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CCJ — Predicate Candidate Screening
28 FDA 510(k) clearances under this product code; the 50 most recent screened below.
168 daysmedian FDA review time
537 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253119 | CoSense ETCO Monitor | Capnia, Inc. | 2026-05-29 | 247 | 0 |
| K211918 | iCOquit® Smokerlyzer® | Bedfont Scientific, Ltd. | 2021-12-21 | 183 | 0 |
| K201206 | Pivot Breath Sensor | Carrot, Inc. | 2021-06-30 | 422 | 0 |
| K173238 | ToxCO | Bedfont Scientific, Ltd. | 2019-04-04 | 546 | 0 |
| K171129 | CO Check Pro, CO Screen | MD Diagnostics Limited | 2018-03-02 | 319 | 0 |
| K171408 | Carbon Monoxide Breath Sensor System (COBSS) | Carrot Sense, Inc. | 2017-09-29 | 140 | 0 |
| K151107 | CoSense ETCO Monitor | Capnia, Inc. | 2015-07-22 | 86 | 1 |
| K130036 | COSENSE CO MONITOR | Capnia, Inc. | 2014-01-14 | 372 | 0 |
| K121768 | COSENSE | Capnia, Inc. | 2012-10-31 | 138 | 0 |
| K082315 | EC50 MICRO+ SMOKERLYZER | Bedfont Scientific, Ltd. | 2010-02-01 | 537 | 0 |
| K080278 | TABATABA COTESTER | Fim Medical | 2008-11-28 | 298 | 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 |
| K950197 | MICROCO | Micro Direct, Inc. | 1996-10-17 | 638 | 0 |
| K952694 | CO BREATH ANALYSIS MODULE & MONOXOL II | Bacharach, Inc. | 1996-01-29 | 229 | 0 |
| K904633 | SPIROLOOP, MODIFICATION | Pneumedics, Inc. | 1991-03-12 | 168 | 0 |
| K902113 | VITALOGRAPH - BREATHCO MONITOR | Mcneill Intl., Inc. | 1990-10-26 | 168 | 0 |
| K900322 | CO/CMD-1 | Spirometrics, Inc. | 1990-04-30 | 97 | 0 |
| K892841 | BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR | Bedfont Technical Instruments , Ltd. | 1989-10-05 | 170 | 0 |
| K892524 | VITALOGRAPH-BREATHCO MONITOR | Vitalograph , Ltd. | 1989-05-05 | 24 | 0 |
| K863420 | VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR | Vitalograph , Ltd. | 1987-01-15 | 133 | 0 |
| K843845 | CO TEST | Erich Jaeger, Inc. | 1984-10-12 | 11 | 0 |
| K833739 | CD-102 CARBON DIOXIDE ANALYZER/RECOR | Instrumentarium Corp. | 1983-12-16 | 52 | 0 |
| K832655 | ECOLYZER #200/COHB ANALYZER SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-26 | 49 | 0 |
| K802891 | ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT | Sherwood Medical Co. | 1980-12-19 | 32 | 0 |
| K781871 | DIFFUSION OPTION, OMNI-LAB | Ohio Medical Products | 1979-01-02 | 60 | 0 |
| K781746 | MINICO | Catalyst Research Corp. | 1978-12-05 | 48 | 0 |
| K760169 | DIFFUSION SYSTEM, SINGLE-BREATH (47404A) | Hewlett-Packard Co. | 1976-07-20 | 14 | 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