510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902187Substantially Equivalent

Polaron

Nurion Industries, Paoli PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902187 is the FDA 510(k) clearance record for POLARON, a class I device, cleared for Nurion Industries on under FDA product code HPG (Aid, Vision, Electronic, Battery-Powered). FDA records list 3 510(k) clearances for Nurion Industries, from to . As of , FDA records show no recalls naming K902187.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HPG Aid, Vision, Electronic, Battery-Powered
Regulation
21 CFR 886.5900
Device class
Class I
Review panel
Ophthalmic
Applicant
Nurion Industries Station Sq. Three, Paoli PA
Third party review
No

Clearances, product code HPG

Trailing 12 months

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

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