Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cefla S.C. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
190 daysmedian FDA review time
275 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260716 | Neowise | Cefla S.C. | 2026-05-04 | 60 | 0 |
| K252353 | myray ProXIma X6 | Cefla S.C. | 2026-03-10 | 224 | 0 |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MM | Cefla S.C. | 2024-04-01 | 367 | 0 |
| K231990 | Apex Locator | Cefla S.C. | 2024-02-13 | 223 | 0 |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | 2023-01-17 | 29 | 0 |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR | Cefla S.C. | 2022-05-09 | 231 | 0 |
| K220664 | NewTom 7G | Cefla S.C. | 2022-05-06 | 60 | 0 |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | 2022-01-20 | 24 | 0 |
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACT | Cefla S.C. | 2020-04-09 | 24 | 0 |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | 2019-04-24 | 55 | 0 |
| K183448 | NewTom 5G XL | Cefla S.C. | 2019-03-08 | 86 | 0 |
| K161848 | Family of Steam sterilizers B17 B22 Series | Cefla S.C. | 2017-02-23 | 233 | 0 |
| K163519 | RX DC | Cefla S.C. | 2017-01-13 | 29 | 0 |
| K161900 | HYPERION X5 | Cefla S.C. | 2016-12-09 | 151 | 0 |
| K151597 | Family of Steam Sterilizers B 28 series | Cefla S.C. | 2016-03-04 | 266 | 0 |
| K152162 | Myray- HYPERION X5 | Cefla S.C. | 2015-12-24 | 143 | 0 |
| K133412 | S200, S300 | Cefla S.C. | 2015-01-08 | 427 | 0 |
| K130834 | R7 | Cefla S.C. | 2013-10-08 | 196 | 0 |
| K123381 | HYPERION X9 | Cefla S.C. | 2013-05-10 | 190 | 0 |
| K092917 | STERN'S S250 NORDAM | Cefla S.C. | 2010-06-24 | 275 | 0 |
| K081088 | MYRAY SKYVIEW | Cefla S.C. | 2008-11-06 | 204 | 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