Contract Medical International, GmbH: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Contract Medical International, GmbH” (first 2015, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 68 days. Since 2017 the median was 30 days, against 62 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 |
|---|---|---|
| 2015 | 1 | 304 |
| 2016 | 1 | 68 |
| 2017 | 0 | — |
| 2018 | 1 | 192 |
| 2019 | 0 | — |
| 2020 | 1 | 25 |
| 2021 | 0 | — |
| 2022 | 1 | 29 |
| 2023 | 0 | — |
| 2024 | 1 | 128 |
| 2025 | 1 | 30 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Contract Medical International, GmbH took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 62 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent Contract Medical International, GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca | DYB | 2025-03-16 | 30 |
| K240957 | Catapult Guide Sheath | DYB | 2024-08-14 | 128 |
| K221914 | Catapult Guide Sheath | DYB | 2022-07-29 | 29 |
| K203179 | Fortress Introducer Sheath System | DYB | 2020-11-20 | 25 |
| K181463 | DuraSheath Introducer Sheath System | DYB | 2018-12-13 | 192 |
| K153197 | Fortress Introducer Sheath SYstem | DYB | 2016-01-11 | 68 |
| K142357 | DuraSheath Introducer Sheath System | DYB | 2015-06-25 | 304 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-07-30.
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.
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.
- Contract Latex Dippers Sdn Bhd (5 510(k)s)
- Contract Medical Intl. GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Contract Medical International, GmbH?
FDA lists 7 510(k) clearances under the applicant name “Contract Medical International, GmbH” (first 2015, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Contract Medical International, GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Contract Medical International, GmbH is 68 days. Since 2017: 30 days, versus 62 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Contract Medical International, GmbH?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 7).
Next steps
- See all 7 Contract Medical International, GmbH clearances with predicates and recalls
- Run predicate analysis for product code DYB, Contract Medical International, GmbH'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.