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

Negative Pressure Wound Therapy Powered Suction Pump

21 CFR 878.4780 / General, Plastic Surgery
FDA source (opens on fda.gov)

OMP is the FDA product code for Negative Pressure Wound Therapy Powered Suction Pump, a class II device type, regulated under 21 CFR 878.4780. FDA's definition for this code 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 chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns...". As of , FDA records hold 214 510(k) clearances under this code, the most recent dated , and 47 recalls.

Classification record

Product code
OMP
Device name
Negative Pressure Wound Therapy Powered Suction Pump
FDA definition
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 chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
215
Ingested recalls
47

Clearances, product code OMP

By decision year
215 clearances under product code OMP with a decision year between 1997 and 2026, 2015 the highest year at 20.
Show the numbers
510(k) clearances under FDA product code OMP by decision year
YearClearances
19971
20001
20022
20032
20041
20053
20067
20076
20088
20098
20106
20116
201211
201311
201410
201520
201619
201711
201813
201915
20206
20219
202210
20238
20249
20255
20267

Applicants with the most clearances

Product code OMP
Applicants holding the most 510(k) clearances under product code OMP
ApplicantClearances
KCI USA, Inc.33
Smith & Nephew Medical Ltd21
Genadyne Biotechnologies, Inc.16
Smith & Nephew, Inc.14
Kci USA, Inc. (Kinetic Concepts, Inc.)13
Medela AG13
Cardinalhealth7
Molnlycke Health Care, US LLC7
3M Healthcare Business Group4
Blue Sky Medical Group Incorporated4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 82 companies shown, in name order