510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810653Substantially Equivalent

Vinyl Ice Bag

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

K810653 is the FDA 510(k) clearance record for VINYL ICE BAG, a class I device, cleared for First Industries, Inc. on under FDA product code KYR (Bag, Ice). FDA records list 6 510(k) clearances for First Industries, Inc., from to . As of , FDA records show no recalls naming K810653.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KYR Bag, Ice
Regulation
21 CFR 880.6050
Device class
Class I
Review panel
General Hospital
Applicant
First Industries, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KYR

Trailing 12 months

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

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