510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080117Substantially Equivalent

Patient Isolation Unit, Model G019-1000

Gentex Corporation, Rancho Cucamonga CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K080117 is the FDA 510(k) clearance record for PATIENT ISOLATION UNIT, MODEL G019-1000, a class II device, cleared for Gentex Corporation on under FDA product code LGM (Chamber, Patient Isolation). FDA records list 3 510(k) clearances for Gentex Corporation, from to . As of , FDA records show no recalls naming K080117.

Clearance record

Decision date
Received
(379 days to decision)
Product code
LGM Chamber, Patient Isolation
Regulation
21 CFR 880.5450
Device class
Class II
Review panel
General Hospital
Applicant
Gentex Corporation 11525 Sixth St., Rancho Cucamonga CA
510(k) summary
Statement
Third party review
No

Clearances, product code LGM

Trailing 12 months

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

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