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
K962983Substantially Equivalent

Sterile Soft-Temp

Adroit Medical Systems, Inc., Loudon TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962983 is the FDA 510(k) clearance record for STERILE SOFT-TEMP, a class II device, cleared for Adroit Medical Systems, Inc. on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list 6 510(k) clearances for Adroit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K962983.

Clearance record

Decision date
Received
(162 days to decision)
Product code
ILO Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
Device class
Class II
Review panel
Physical Medicine
Applicant
Adroit Medical Systems, Inc. 1146 Carding Machine Rd., Loudon TN
510(k) summary
Summary
Third party review
No

Clearances, product code ILO

Trailing 12 months

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

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