510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994381Substantially Equivalent

Prospore2 Self-Contained Biological Indicator

Raven Biological Laboratories, Inc., Omaha NE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994381 is the FDA 510(k) clearance record for PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR, a class II device, cleared for Raven Biological Laboratories, Inc. on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list 15 510(k) clearances for Raven Biological Laboratories, Inc., from to . As of , FDA records show one recall naming K994381.

Clearance record

Decision date
Received
(458 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Raven Biological Laboratories, Inc. 8607 Park Dr., Omaha NE
510(k) summary
Summary
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