510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905657Substantially Equivalent

Sonopak/qs, Sonopak

Bioresearch, Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905657 is the FDA 510(k) clearance record for SONOPAK/QS, SONOPAK, a class I device, cleared for Bioresearch on under FDA product code NFQ (Device, Dental Sonography, For Monitoring Jaw Sounds). FDA records list one 510(k) clearance for Bioresearch. As of , FDA records show no recalls naming K905657.

Clearance record

Decision date
Received
(149 days to decision)
Product code
NFQ Device, Dental Sonography, For Monitoring Jaw Sounds
Regulation
21 CFR 872.2050
Device class
Class I
Review panel
Dental
Applicant
Bioresearch 4113 N. Port Washington Rd., Milwaukee WI
Third party review
No

Clearances, product code NFQ

Trailing 12 months

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

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