510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802165Substantially Equivalent

Sherwood Ventilatory Muscle Trainer

Sherwood Medical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802165 is the FDA 510(k) clearance record for SHERWOOD VENTILATORY MUSCLE TRAINER, a class I device, cleared for Sherwood Medical Co. on under FDA product code BYW (Device, Rebreathing). FDA records list 191 510(k) clearances for Sherwood Medical Co., from to . As of , FDA records show no recalls naming K802165.

Clearance record

Decision date
Received
(18 days to decision)
Product code
BYW Device, Rebreathing
Regulation
21 CFR 868.5675
Device class
Class I
Review panel
Anesthesiology
Applicant
Sherwood Medical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BYW

Trailing 12 months

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

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