510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K841090Substantially Equivalent

Ventilator External Body Negative Press

Porta-Lung Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841090 is the FDA 510(k) clearance record for VENTILATOR EXTERNAL BODY NEGATIVE PRESS, a class II device, cleared for Porta-Lung Co. on under FDA product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)). FDA records list one 510(k) clearance for Porta-Lung Co. As of , FDA records show no recalls naming K841090.

Clearance record

Decision date
Received
(78 days to decision)
Product code
BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Regulation
21 CFR 868.5935
Device class
Class II
Review panel
Anesthesiology
Applicant
Porta-Lung Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BYT

Trailing 12 months

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

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