Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C.F. Electronics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
261 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955659 | DRUGBOX | C.F. Electronics, Inc. | 1996-05-14 | 154 | 0 |
| K926161 | RES Q AIR SYSTEM MODEL HT-1000 | C.F. Electronics, Inc. | 1993-08-26 | 261 | 0 |
| K932570 | MARK I HUMIDIFIER | C.F. Electronics, Inc. | 1993-08-25 | 90 | 0 |
| K922786 | THERM O DRUG MODEL HT-747 | C.F. Electronics, Inc. | 1993-01-27 | 232 | 0 |
| K921395 | HOT SACK | C.F. Electronics, Inc. | 1992-09-02 | 162 | 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