510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972549Substantially Equivalent

Simpulse

KCI USA, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972549 is the FDA 510(k) clearance record for SIMPULSE, a class II device, cleared for Kinetic Concepts, Inc. on under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure). FDA records list 76 510(k) clearances for KCI USA, INC., from to . As of , FDA records show no recalls naming K972549.

Clearance record

Decision date
Received
(133 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
Kinetic Concepts, Inc. P.O. Box 659508, San Antonio TX
510(k) summary
Summary
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