Cleared Traditional

K112853 - VOLTERA POWERED SUCTION PUMP

K112853 is an FDA 510(k) clearance for VOLTERA POWERED SUCTION PUMP, manufactured by Suzric Enterprise Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 407-day FDA review.

K112853 · Suzric Enterprise Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
407d
Days
Class 2
Risk

K112853 is an FDA 510(k) clearance for the VOLTERA POWERED SUCTION PUMP. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Suzric Enterprise Co., Ltd. (Taoyuan County, TW). The FDA issued a Cleared decision on November 9, 2012 after a review of 407 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 - K112853

510(k) Number K112853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2011
Decision Date November 09, 2012
Days to Decision 407 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
292d slower than avg
Panel avg: 115d · This submission: 407d
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 K112853.
FORYOU NPWT DEVICE
K113236 · Foryou Medical Electronics Co, Ltd. · Feb 2013
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
K122132 · Molnlycke Health Care · Jan 2013
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
K123878 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Jan 2013
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
K121883 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Oct 2012
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
K120499 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Oct 2012
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K113678 · Medela AG · Oct 2012
K112853 · VOLTERA POWERED SUCTION PUMP
Download PDF FDA Summary Suzric Enterprise Co.…