Kci USA, Inc. (Kinetic Concepts, Inc.)

FDA Regulatory Profile

Kci USA, Inc. (Kinetic Concepts, Inc.) has 0 FDA recalls, 0 inspections, 13 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jan 26, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances13Oct 4, 2026Not statedCurrent
Inspections0Oct 27, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemJan 26, 2017
K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsOct 4, 2016
K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...Jun 20, 2016
K141017PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH…Aug 20, 2015
K133232PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM…Mar 24, 2014
K123878PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSINGJan 15, 2013
K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KITOct 11, 2012
K120499ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEMOct 5, 2012
K103156V.A.C. VERAFLO CLEANSE DRESSING SYSTEMMar 14, 2011
K102956V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM…Dec 15, 2010
K100657V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA…Sep 17, 2010
K093526V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING…Mar 10, 2010
K062227V.A.C. THERAPY SYSTEMOct 4, 2006