Kci USA, Inc. (Kinetic Concepts, Inc.)
San Antonio, TX, US
Kci USA, Inc. (Kinetic Concepts, Inc.) appears in FDA device records in San Antonio, TX. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Kci USA, Inc. (Kinetic Concepts, Inc.) between 2006 and 2017. The busiest year on record is 2010, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162790 | V.A.C.ULTA Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | |
| K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings | OMP | Substantially Equivalent | |
| K160451 | V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... | OMP | Substantially Equivalent | |
| K141017 | PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, | OMP | Substantially Equivalent | |
| K133232 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES | OMP | Substantially Equivalent | |
| K123878 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING | OMP | Substantially Equivalent | |
| K121883 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT | OMP | Substantially Equivalent | |
| K120499 | ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM | OMP | Substantially Equivalent | |
| K103156 | V.A.C. VERAFLO CLEANSE DRESSING SYSTEM | OMP | Substantially Equivalent | |
| K102956 | V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING | OMP | Substantially Equivalent | |
| K100657 | V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U | OMP | Substantially Equivalent | |
| K093526 | V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D | OMP | Substantially Equivalent | |
| K062227 | V.A.C. THERAPY SYSTEM | OMP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain