510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862509Substantially Equivalent

Charcoal Laser Smoke Filter Catalog No. 901103-000

Lifestream Int'L, Inc., Sugar Land TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862509 is the FDA 510(k) clearance record for CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000, a class I device, cleared for Lifestream Int'L, Inc. on under FDA product code JDY (Evacuator, Vapor, Cement Monomer). FDA records list 23 510(k) clearances for Lifestream Int'L, Inc., from to . As of , FDA records show no recalls naming K862509.

Clearance record

Decision date
Received
(22 days to decision)
Product code
JDY Evacuator, Vapor, Cement Monomer
Regulation
21 CFR 888.4220
Device class
Class I
Review panel
Orthopedic
Applicant
Lifestream Int'L, Inc. 525 Julie Rivers Dr., Sugar Land TX
Third party review
No

Clearances, product code JDY

Trailing 12 months

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

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