510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870045Substantially Equivalent

Skytron Model 610-2

Skytron, LLC, Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870045 is the FDA 510(k) clearance record for SKYTRON MODEL 610-2, a class II device, cleared for Skytron, Div. the Kmw Group, Inc. on under FDA product code INX (Bed, Air Fluidized). FDA records list 19 510(k) clearances for Skytron, LLC, from to . As of , FDA records show no recalls naming K870045.

Clearance record

Decision date
Received
(30 days to decision)
Product code
INX Bed, Air Fluidized
Regulation
21 CFR 890.5160
Device class
Class II
Review panel
Physical Medicine
Applicant
Skytron, Div. the Kmw Group, Inc. 5000 36th St., SE, Grand Rapids MI
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