Cleared Traditional

K260302 - B·R·A·H·M·S MR-proADM KRYPTOR

Also marketed or referenced as:
B·R·A·H·M·S MR-proADM KRYPTOR CAL B·R·A·H·M·S MR-proADM KRYPTOR QC
K260302 · B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
266d
Days
-
Risk

K260302 is an FDA 510(k) clearance for the B·R·A·H·M·S MR-proADM KRYPTOR.

Submitted by B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) (Hennigsdorf, DE). The FDA issued a Cleared decision on October 23, 2026 after a review of 266 days - an extended review cycle.

This device falls under the Microbiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260302

510(k) Number K260302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2026
Decision Date October 23, 2026
Days to Decision 266 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 102d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

SJQ Device Classification - Class ,

Product Code SJQ
Device Class -
K260302 · B·R·A·H·M·S MR-proADM KRYPTOR
Download PDF FDA Summary B·R·A·H·M·S GmbH (par…