Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kci USA, Inc. (Kinetic Concepts, Inc.) · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
227 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162790 | V.A.C.ULTA Negative Pressure Wound Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2017-01-26 | 114 | 1 |
| K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems wi | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2016-10-04 | 85 | 0 |
| K160451 | V. A.C. VeraFlo Cleanse Choice Dressing System for use with | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2016-06-20 | 123 | 0 |
| K141017 | PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PRE | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2015-08-20 | 486 | 0 |
| K133232 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSIN | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2014-03-24 | 154 | 0 |
| K123878 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSIN | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2013-01-15 | 29 | 8 |
| K121883 | PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSIN | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012-10-11 | 105 | 0 |
| K120499 | ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012-10-05 | 227 | 0 |
| K103156 | V.A.C. VERAFLO CLEANSE DRESSING SYSTEM | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2011-03-14 | 139 | 0 |
| K102956 | V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SIL | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010-12-15 | 72 | 0 |
| K100657 | V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. U | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010-09-17 | 193 | 0 |
| K093526 | V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THER | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010-03-10 | 114 | 0 |
| K062227 | V.A.C. THERAPY SYSTEM | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2006-10-04 | 63 | 2 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda