510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073712Substantially Equivalent

Soft Air, Model Sa 4000 and Mistral Air, Model Ma0100

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

K073712 is the FDA 510(k) clearance record for SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100, a class II device, cleared for Adroit Medical Systems, Inc. on under FDA product code DWJ (System, Thermal Regulating). FDA's definition for product code DWJ reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 6 510(k) clearances for Adroit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K073712.

Clearance record

Decision date
Received
(158 days to decision)
Product code
DWJ System, Thermal Regulating
Regulation
21 CFR 870.5900
Device class
Class II
Review panel
Cardiovascular
Applicant
Adroit Medical Systems, Inc. 1146 Carding Machine Rd., Loudon TN
510(k) summary
Statement
Third party review
No

Clearances, product code DWJ

Trailing 12 months
5 clearances under product code DWJ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20261
August 20262
September 20260
October 20260