510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922590Substantially Equivalent

Bio-Pen Srk II Calculator

Bio-Rad, Glendale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922590 is the FDA 510(k) clearance record for BIO-PEN SRK II CALCULATOR, a class III device, cleared for Bio-Rad on under FDA product code LQB (Medical Computers And Software For Ophthalmic Use). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K922590.

Clearance record

Decision date
Received
(427 days to decision)
Product code
LQB Medical Computers And Software For Ophthalmic Use
Device class
Class III
Review panel
Unknown
Applicant
Bio-Rad 635 W. Colorado St., Glendale CA
510(k) summary
Statement
Third party review
No

Clearances, product code LQB

Trailing 12 months

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

FDA records show no clearances under product code LQB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LQB, 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