510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171338Substantially Equivalent

B R A H M S PCT sensitive KRYPTOR

B.R.A.H.M.S GmbH, Henningsdorf, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171338 is the FDA 510(k) clearance record for B R A H M S PCT sensitive KRYPTOR, a class II device, cleared for Brahms GmbH on under FDA product code PRI (Procalcitonin Assay). FDA's definition for product code PRI reads: "To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as...". FDA records list 2 510(k) clearances for Brahms GmbH, from to . As of , FDA records show no recalls naming K171338.

Clearance record

Decision date
Received
(23 days to decision)
Product code
PRI Procalcitonin Assay
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Applicant
Brahms GmbH Neuendorfstr. 25, Henningsdorf, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PRI

Trailing 12 months

FDA records hold no clearances under product code PRI in the trailing twelve months.

FDA records show no clearances under product code PRI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PRI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260