510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K163144Substantially Equivalent

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

Gke-GmbH, Waldems, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163144 is the FDA 510(k) clearance record for gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI), a class II device, cleared for Gke-GmbH on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list one 510(k) clearance for Gke-GmbH. As of , FDA records show no recalls naming K163144.

Clearance record

Decision date
Received
(149 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Gke-GmbH Auf Der Lind 10, Waldems, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRC

Trailing 12 months
1 clearance under product code FRC in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260