510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K972022Substantially Equivalent

Zak-2000

Cardio Systems, Inc., Carrollton TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972022 is the FDA 510(k) clearance record for ZAK-2000, a class II device, cleared for Cardio Systems, Inc. on under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure). FDA records list 9 510(k) clearances for Cardio Systems, Inc., from to . As of , FDA records show no recalls naming K972022.

Clearance record

Decision date
Received
(234 days to decision)
Product code
FNM Mattress, Air Flotation, Alternating Pressure
Regulation
21 CFR 880.5550
Device class
Class II
Review panel
General Hospital
Applicant
Cardio Systems, Inc. 1201 N. Interstate 35, Carrollton TX
510(k) summary
Statement
Third party review
No

Clearances, product code FNM

Trailing 12 months

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

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