510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822711Substantially Equivalent

Anti-Mist, Anti-Fog Eyeglass & Dental

Parker Laboratories, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822711 is the FDA 510(k) clearance record for ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL, a class I device, cleared for Parker Laboratories, Inc. on under FDA product code FAX (Bougie, Urological). FDA records list 30 510(k) clearances for Parker Laboratories, Inc., from to . As of , FDA records show no recalls naming K822711.

Clearance record

Decision date
Received
(57 days to decision)
Product code
FAX Bougie, Urological
Regulation
21 CFR 876.5520
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Parker Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FAX

Trailing 12 months

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

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