Cleared Traditional

K121817 - VCARE A

K121817 is an FDA 510(k) clearance for VCARE A, manufactured by IVT Medical, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 454-day FDA review.

K121817 · IVT Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
454d
Days
Class 2
Risk

K121817 is an FDA 510(k) clearance for the VCARE A. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by IVT Medical, Ltd. (Efrat, IL). The FDA issued a Cleared decision on September 17, 2013 after a review of 454 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 - K121817

510(k) Number K121817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2012
Decision Date September 17, 2013
Days to Decision 454 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
339d slower than avg
Panel avg: 115d · This submission: 454d
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 K121817.
KULAVAC
K122490 · CG Bio Co., Ltd. · Nov 2013
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
K132446 · Smith & Nephew, Inc. · Oct 2013
EXTRICARE 100CC/ 250CC/ 400CC CANISTERS
K132252 · Devon Medical · Sep 2013
EXTRICARE NPWT FOOT DRESSING
K131464 · Devon Medical, Inc. · Aug 2013
KCI NPWT GAUZE DRESSING
K123507 · Kci USA, Inc. · Apr 2013
FORYOU NPWT DEVICE
K113236 · Foryou Medical Electronics Co, Ltd. · Feb 2013
K121817 · VCARE A
Download PDF FDA Summary IVT Medical, Ltd.