510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K841893Substantially Equivalent

Maxaman

Cryo2 Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841893 is the FDA 510(k) clearance record for MAXAMAN, a class II device, cleared for Cryo2 Corp. on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list one 510(k) clearance for Cryo2 Corp. As of , FDA records show no recalls naming K841893.

Clearance record

Decision date
Received
(115 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Cryo2 Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BTL

Trailing 12 months

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

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