510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934689Substantially Equivalent

Low Air Loss Mattress, Modification

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

K934689 is the FDA 510(k) clearance record for LOW AIR LOSS MATTRESS, MODIFICATION, a class II device, cleared for Cardio Systems, Inc. on under FDA product code INX (Bed, Air Fluidized). FDA records list 9 510(k) clearances for Cardio Systems, Inc., from to . As of , FDA records show no recalls naming K934689.

Clearance record

Decision date
Received
(163 days to decision)
Product code
INX Bed, Air Fluidized
Regulation
21 CFR 890.5160
Device class
Class II
Review panel
Physical Medicine
Applicant
Cardio Systems, Inc. P.O. Box 29923, Dallas TX
510(k) summary
Statement
Third party review
No

Clearances, product code INX

Trailing 12 months

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

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