510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163223Substantially Equivalent

ORCA (tm) - Operational Rescue Containment Apparatus

Isovac Products LLC, Romeoville IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163223 is the FDA 510(k) clearance record for ORCA (tm) - Operational Rescue Containment Apparatus, a class II device, cleared for Isovac Products, LLC on under FDA product code LGM (Chamber, Patient Isolation). FDA records list 2 510(k) clearances for Isovac Products, LLC, from to . As of , FDA records show no recalls naming K163223.

Clearance record

Decision date
Received
(351 days to decision)
Product code
LGM Chamber, Patient Isolation
Regulation
21 CFR 880.5450
Device class
Class II
Review panel
General Hospital
Applicant
Isovac Products, LLC 1306 Enterprise Dr., Unit C, Romeoville IL
510(k) summary
Summary PDF
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