Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Creo Medical, Ltd. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
265 daysmedian FDA review time
334 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | 2025-06-06 | 266 | 0 |
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) | Creo Medical, Ltd. | 2025-02-05 | 132 | 0 |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. | 2024-08-15 | 31 | 0 |
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | 2023-10-31 | 267 | 0 |
| K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2023-06-26 | 265 | 0 |
| K221672 | Creo Electrosurgical System with NP1 Instrument | Creo Medical, Ltd. | 2023-02-14 | 250 | 0 |
| K200298 | ABI Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2021-01-05 | 334 | 0 |
| K200003 | NP1 Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2020-10-28 | 300 | 0 |
| K192905 | Creo Electrosurgical System with HS1 Hemostasis Accessory | Creo Medical, Ltd. | 2020-03-19 | 156 | 0 |
| K171983 | Creo Medical Electrosurgical System including Speedboat RS2 | Creo Medical, Ltd. | 2017-08-17 | 48 | 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