510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201400Substantially Equivalent

npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™

Aatru Medical, LLC, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201400 is the FDA 510(k) clearance record for npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™, a class II device, cleared for Aatru Medical, LLC on under FDA product code QPX (Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical). FDA's definition for product code QPX reads: "For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Indicated for management of chronic, acute...". FDA records list one 510(k) clearance for Aatru Medical, LLC. As of , FDA records show no recalls naming K201400.

Clearance record

Decision date
Received
(452 days to decision)
Product code
QPX Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
Regulation
21 CFR 878.4683
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Aatru Medical, LLC 1301 E. 9th St., Suite 2700, Cleveland OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QPX

Trailing 12 months

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

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