Cleared Traditional

K080275 - NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM

K080275 is an FDA 510(k) clearance for NPD 1000 NEGATIVE PRESSURE WOUND THERAP..., manufactured by Iasis Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K080275 · Iasis Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
251d
Days
Class 2
Risk

K080275 is an FDA 510(k) clearance for the NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Iasis Medical, Inc. (Hastings, US). The FDA issued a Cleared decision on October 9, 2008 after a review of 251 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Iasis Medical, Inc. devices

FDA 510(k) Submission Details - K080275

510(k) Number K080275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2008
Decision Date October 09, 2008
Days to Decision 251 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 115d · This submission: 251d
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 149
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K080275.
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375 · Smith & Nephew, Inc. · Feb 2009
GENADYNE A4 WOUND VACUUM SYSTEM
K082676 · Genadyne Biotechnologies, Inc. · Dec 2008
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
K082211 · Smith & Nephew, Inc. · Nov 2008
RENASYS EZ
K082426 · Smith & Nephew, Inc. · Sep 2008
MEDELA INVIA WOUND THERAPY
K080357 · Medela AG · Jul 2008
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
K063692 · Kci USA, Inc. · Jun 2007