Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CBL · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
64 daysmedian FDA review time
183 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921803 | SOFNOLIME CARBON DIOXIDE ABSORBENT | Molecular Products , Ltd. | 1992-10-15 | 183 | 0 |
| K897171 | DISPOSABLE CO2 ABSORBER/E | Gibeck, Inc. | 1990-03-13 | 75 | 0 |
| K860147 | CARBON DIOXIDE ABSORBENTS | Dentsply Intl. | 1986-02-28 | 44 | 0 |
| K853571 | MEDIPART SODA LIME MP-3522 | Medipart Jerry Alexander | 1985-10-29 | 64 | 0 |
| K811260 | BARALYME CO2 ABSORBENT | Allied Healthcare Products, Inc. | 1981-05-27 | 21 | 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