510(k) Report

FDA applicant

Rapid Biomedical GmbH

Rimpar, DE7 decisions2008–20230 recalls

FDA records 7 decisions for Rapid Biomedical GmbH (Rimpar, DE) from 2008 to 2023: 7 510(k) clearances. All are in product code MOS (Coil, Magnetic Resonance, Specialty). Since 2016 its 510(k)s took a median of 342 days from receipt to decision, against 41 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Rapid Biomedical GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12010: 12011: 12018: 22020: 12023: 1
2008high 2 (2018) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Rapid Biomedical GmbH by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MOSCoil, Magnetic Resonance, Specialty7decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 342 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 41 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K08325516CH AI Breast Coils 1.5 T and 3 TRapid Biomedical GmbH · 20081cites it
  • K10274831P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3TRapid Biomedical GmbH · 20111cites it

What has FDA decided for it lately?

  • K21348031P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head CoilRapid Biomedical GmbH · 2023
  • K1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH · 2020
  • K1819481.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast CoilRapid Biomedical GmbH · 2018
  • K163661P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex CoilRapid Biomedical GmbH · 2018
  • K10274831P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3TRapid Biomedical GmbH · 2011
  • K10234831P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual Turned Surface Coil 3TRapid Biomedical GmbH · 2010
  • K08325516CH AI Breast Coils 1.5 T and 3 TRapid Biomedical GmbH · 2008

All 7 as Rapid Biomedical GmbH →

Other applicant names beginning “Rapid”

FDA records each applicant name separately; these may or may not be the same firm.

Rapid Medical, Ltd. 12Rapid City Regional Hospital, Inc. 10Rapid Diagnostic Laboratories, Inc. 6Rapid Diagnostics, Inc. 4Rapid Pathogen Screening, Inc. 3Rapid Aid Corp. 3Rapid Injection Systems Corp. 2Rapid Reboot Recovery Products, LLC 2Rapid Mfg. Co. 1Rapid-Aid Ltd./Ltee 1Rapid Response Solutions, LLC 1Rapid Nexus Nanotech Wound Solutions, Inc. 1