510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802687Substantially Equivalent

Speakeasy Commun. System-Comm. Prothesis

Intelligent Software Systems, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802687 is the FDA 510(k) clearance record for SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS, a class II device, cleared for Intelligent Software Systems, Inc. on under FDA product code ILQ (System, Communication, Powered). FDA records list one 510(k) clearance for Intelligent Software Systems, Inc. As of , FDA records show no recalls naming K802687.

Clearance record

Decision date
Received
(98 days to decision)
Product code
ILQ System, Communication, Powered
Regulation
21 CFR 890.3710
Device class
Class II
Review panel
Physical Medicine
Applicant
Intelligent Software Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ILQ

Trailing 12 months

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

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