Rapid Biomedical GmbH: FDA clearances and approvals
Rapid Biomedical GmbH has 7 FDA 510(k) clearances (first 2008, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time: 232 days. Since 2017 its median was 342 days, against 58 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 284 |
| 2019 | 0 | — |
| 2020 | 1 | 235 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 460 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Rapid Biomedical GmbH's cleared 510(k)s took a median 342 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 58 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 7 | 7 |
Review panels
- Radiology (7)
Most recent Rapid Biomedical GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213480 | 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil | MOS | 2023-02-01 | 460 |
| K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support | MOS | 2020-01-31 | 235 |
| K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil | MOS | 2018-11-16 | 119 |
| K163661 | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil | MOS | 2018-03-21 | 449 |
| K102748 | 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T | MOS | 2011-05-13 | 232 |
| K102348 | 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T | MOS | 2010-12-22 | 125 |
| K083255 | 16CH AI BREAST COILS 1.5 T AND 3 T | MOS | 2008-11-21 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Rapid Biomedical GmbH.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Rapid Biomedical GmbH's product codes (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances does Rapid Biomedical GmbH have?
Rapid Biomedical GmbH has 7 FDA 510(k) clearances (first 2008, latest 2023), across 1 product code in 1 review panel.
How long does FDA take to clear Rapid Biomedical GmbH's 510(k)s?
The median time from FDA receipt to decision across Rapid Biomedical GmbH's cleared 510(k)s is 232 days. Since 2017: 342 days, versus 58 days for all cleared 510(k)s in the same product codes.
What devices does Rapid Biomedical GmbH make?
Its most frequent FDA product codes are MOS (Coil, Magnetic Resonance, Specialty, 7).
Has Rapid Biomedical GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Rapid Biomedical GmbH. Related entities may recall under other names.
Next steps
- See all 7 Rapid Biomedical GmbH clearances with predicates and recalls
- Run predicate analysis for product code MOS, Rapid Biomedical GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.