510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803111Substantially Equivalent

Erectaid

Burditt & Calkins-Siemens-Elema, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803111 is the FDA 510(k) clearance record for ERECTAID, a class II device, cleared for Burditt & Calkins-Siemens-Elema on under FDA product code FAE (Prosthesis, Penile). FDA records list 10 510(k) clearances for Burditt & Calkins-Siemens-Elema, from to . As of , FDA records show no recalls naming K803111.

Clearance record

Decision date
Received
(44 days to decision)
Product code
FAE Prosthesis, Penile
Regulation
21 CFR 876.3630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Burditt & Calkins-Siemens-Elema 135 S. Lasalle, Chicago IL
Third party review
No

Clearances, product code FAE

Trailing 12 months

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

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