510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K830975Substantially Equivalent

Plan a Life

New Directions Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830975 is the FDA 510(k) clearance record for PLAN A LIFE, a class I device, cleared for New Directions Co. on under FDA product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)). FDA records list one 510(k) clearance for New Directions Co. As of , FDA records show no recalls naming K830975.

Clearance record

Decision date
Received
(40 days to decision)
Product code
JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Regulation
21 CFR 862.1435
Device class
Class I
Review panel
Clinical Chemistry
Applicant
New Directions Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JIN

Trailing 12 months

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

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