Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Rapid Biomedical GmbH · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

232 daysmedian FDA review time
460 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K21348031P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head CoilRapid Biomedical GmbH2023-02-014600
K1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH2020-01-312350
K1819481.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic BreasRapid Biomedical GmbH2018-11-161190
K163661P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex CoilRapid Biomedical GmbH2018-03-214490
K10274831P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL Rapid Biomedical GmbH2011-05-132320
K10234831P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFRapid Biomedical GmbH2010-12-221250
K08325516CH AI BREAST COILS 1.5 T AND 3 TRapid Biomedical GmbH2008-11-21170

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