Cleared Traditional

K133333 - UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT

K133333 is an FDA 510(k) clearance for UNI NPWT FOAM DRESSING KIT, manufactured by Blue Ocean Medical Product, LLC. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K133333 · Blue Ocean Medical Product, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
428d
Days
Class 2
Risk

K133333 is an FDA 510(k) clearance for the UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSIN.... Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Blue Ocean Medical Product, LLC (Crofton, US). The FDA issued a Cleared decision on December 31, 2014 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K133333

510(k) Number K133333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2013
Decision Date December 31, 2014
Days to Decision 428 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
313d slower than avg
Panel avg: 115d · This submission: 428d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMP Device Classification - Class 2, Special Controls

Product Code OMP Negative Pressure Wound Therapy Powered Suction Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OMP Negative Pressure Wound Therapy Powered Suction Pump

All 214
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K133333.
NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit
K143301 · Integrated Healing Technologies · Mar 2015
NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit
K142956 · Integrated Healing Technologies · Feb 2015
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
K143362 · Devon Medical Products · Feb 2015
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K141926 · Medela AG · Dec 2014
NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT
K140022 · Cork Medical Products, LLC · Oct 2014
extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit
K140634 · Devon Medical, Inc. · Sep 2014
K133333 · UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT
Download PDF FDA Summary Blue Ocean Medical Pr…