510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813214Substantially Equivalent

Infant Phototherapy Mask

Montrose Phototherapy Supply, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813214 is the FDA 510(k) clearance record for INFANT PHOTOTHERAPY MASK, a class I device, cleared for Montrose Phototherapy Supply on under FDA product code FOK (Pad, Neonatal Eye). FDA records list 2 510(k) clearances for Montrose Phototherapy Supply. As of , FDA records show no recalls naming K813214.

Clearance record

Decision date
Received
(30 days to decision)
Product code
FOK Pad, Neonatal Eye
Regulation
21 CFR 880.5270
Device class
Class I
Review panel
General Hospital
Applicant
Montrose Phototherapy Supply 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FOK

Trailing 12 months

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

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