510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K082415Substantially Equivalent

Prodigy Npwt System Model Prodigy 800V

Premco Medical Systems, Inc., New Rochelle NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K082415 is the FDA 510(k) clearance record for PRODIGY NPWT SYSTEM MODEL PRODIGY 800V, a class II device, cleared for Premco Medical Systems, Inc. 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 one 510(k) clearance for Premco Medical Systems, Inc. As of , FDA records show no recalls naming K082415.

Clearance record

Decision date
Received
(96 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
Premco Medical Systems, Inc. 699 Main St., New Rochelle NY
510(k) summary
Statement
Third party review
Yes

Clearances, product code OMP

Trailing 12 months
9 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 20261