510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863910Substantially Equivalent

Raincoat

Artec Environmental Monitoring Division, Noblesville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863910 is the FDA 510(k) clearance record for RAINCOAT, a class I device, cleared for Artec Environmental Monitoring Division on under FDA product code BZO (Set, Tubing And Support, Ventilator (W Harness)). FDA records list 7 510(k) clearances for Artec Environmental Monitoring Division, from to . As of , FDA records show no recalls naming K863910.

Clearance record

Decision date
Received
(12 days to decision)
Product code
BZO Set, Tubing And Support, Ventilator (W Harness)
Regulation
21 CFR 868.5975
Device class
Class I
Review panel
Anesthesiology
Applicant
Artec Environmental Monitoring Division P.O. Box 68, Noblesville IN
Third party review
No

Clearances, product code BZO

Trailing 12 months

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

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