510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K143301Substantially Equivalent

NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit

Integrated Healing Technologies, Franklin TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143301 is the FDA 510(k) clearance record for NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit, a class II device, cleared for Integrated Healing Technologies on under FDA product code OMP (Negative Pressure Wound Therapy Powered Suction Pump). FDA's definition for product code OMP 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. The Device is indicated for management of...". FDA records list 2 510(k) clearances for Integrated Healing Technologies, from to . As of , FDA records show no recalls naming K143301.

Clearance record

Decision date
Received
(106 days to decision)
Product code
OMP Negative Pressure Wound Therapy Powered Suction Pump
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Integrated Healing Technologies 103 Forrest Crossing Blvd. Suite 103, Franklin TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMP

Trailing 12 months
8 clearances under product code OMP in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code OMP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20263
June 20262
July 20260
August 20260
September 20261
October 20260