Creo Medical, Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Creo Medical, Ltd.” (first 2017, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 258 days. Since 2017 the median was 258 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 48 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 228 |
| 2021 | 1 | 334 |
| 2022 | 0 | — |
| 2023 | 3 | 265 |
| 2024 | 1 | 31 |
| 2025 | 2 | 199 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Creo Medical, Ltd. took a median 258 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 5 | 5 |
| NEY | System, Ablation, Microwave And Accessories | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Creo Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | KNS | 2025-06-06 | 266 |
| K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) | GEI | 2025-02-05 | 132 |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | KNS | 2024-08-15 | 31 |
| K230328 | Speedboat Flush SB1 Instrument | KNS | 2023-10-31 | 267 |
| K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | NEY | 2023-06-26 | 265 |
| K221672 | Creo Electrosurgical System with NP1 Instrument | NEY | 2023-02-14 | 250 |
| K200298 | ABI Instrument, Creo Electrosurgical System | NEY | 2021-01-05 | 334 |
| K200003 | NP1 Instrument, Creo Electrosurgical System | NEY | 2020-10-28 | 300 |
| K192905 | Creo Electrosurgical System with HS1 Hemostasis Accessory | KNS | 2020-03-19 | 156 |
| K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | KNS | 2017-08-17 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Creo Medical, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Creo Medical, Ltd. is the lead sponsor of 4 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06869122: Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK (Recruiting, started 2025-07-14)
- NCT06689488: Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates (Recruiting, started 2025-06-17)
- NCT05786625: Bronchoscopic Microwave Ablation of Lung Tissue (Active not recruiting, started 2023-05-04)
- NCT02372552: Microwave Coagulation Using CROMA Electrosurgical System (Completed, started 2015-08)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Creo Quality, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Creo Medical, Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Creo Medical, Ltd.” (first 2017, latest 2025), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Creo Medical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Creo Medical, Ltd. is 258 days. Since 2017: 258 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Creo Medical, Ltd.?
The most frequent FDA product codes under this applicant name are KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 5); NEY (System, Ablation, Microwave And Accessories, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 10 Creo Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KNS, Creo Medical, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.