Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kinetic Concepts, Inc. — Predicate Candidate Screening
48 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
265 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050261 | V.A.C. GRANUFOAM SILVER PROTECTION DRESSING | Kinetic Concepts, Inc. | 2005-05-26 | 111 | 0 |
| K041642 | V.A.C. GRANUFOAM SILVER DRESSING | Kinetic Concepts, Inc. | 2005-01-25 | 222 | 0 |
| K032310 | MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS | Kinetic Concepts, Inc. | 2003-10-10 | 74 | 2 |
| K022011 | V.A.C. ABDOMINAL DRESSING | Kinetic Concepts, Inc. | 2003-02-26 | 252 | 1 |
| K021500 | VACUUM ASSISTED CLOSURE | Kinetic Concepts, Inc. | 2002-12-20 | 225 | 0 |
| K021501 | V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT | Kinetic Concepts, Inc. | 2002-12-02 | 207 | 0 |
| K020781 | WET CHAMBER | Kinetic Concepts, Inc. | 2002-05-06 | 56 | 0 |
| K992448 | V.A.C. PLUS | Kinetic Concepts, Inc. | 2000-01-18 | 180 | 0 |
| K972176 | HOME CARE BEAD BED | Kinetic Concepts, Inc. | 1998-01-16 | 221 | 0 |
| K972549 | SIMPULSE | Kinetic Concepts, Inc. | 1997-11-18 | 133 | 0 |
| K955243 | BARIAIR | Kinetic Concepts, Inc. | 1997-10-23 | 708 | 1 |
| K970468 | KT AIR BED | Kinetic Concepts, Inc. | 1997-09-05 | 210 | 1 |
| K954320 | MODIFIED PEDIKAIR | Kinetic Concepts, Inc. | 1997-07-18 | 680 | 0 |
| K971548 | AMBUVAC | Kinetic Concepts, Inc. | 1997-05-22 | 24 | 0 |
| K953850 | REDOX | Kinetic Concepts, Inc. | 1996-03-04 | 201 | 0 |
| K944567 | COWBOY X | Kinetic Concepts, Inc. | 1995-06-21 | 275 | 1 |
| K944094 | TRIADYNE | Kinetic Concepts, Inc. | 1995-05-23 | 274 | 0 |
| K945062 | VACPLUS | Kinetic Concepts, Inc. | 1995-03-14 | 151 | 0 |
| K945664 | BARIKARE PLUS | Kinetic Concepts, Inc. | 1995-02-16 | 91 | 0 |
| K940886 | ANNELID | Kinetic Concepts, Inc. | 1994-11-17 | 265 | 0 |
| K933402 | TURBO II | Kinetic Concepts, Inc. | 1994-03-15 | 246 | 0 |
| K931581 | GLENN BED | Kinetic Concepts, Inc. | 1993-10-21 | 205 | 0 |
| K930673 | PREMIUM | Kinetic Concepts, Inc. | 1993-08-02 | 174 | 0 |
| K932215 | COWBOY III | Kinetic Concepts, Inc. | 1993-07-21 | 75 | 0 |
| K920308 | COWBOY II | Kinetic Concepts, Inc. | 1992-08-24 | 214 | 0 |
| K921768 | HAZEL II | Kinetic Concepts, Inc. | 1992-04-29 | 15 | 0 |
| K913611 | COWBOY | Kinetic Concepts, Inc. | 1992-01-13 | 152 | 0 |
| K913998 | PAM PLUS | Kinetic Concepts, Inc. | 1992-01-08 | 124 | 0 |
| K912854 | TURBO | Kinetic Concepts, Inc. | 1991-12-20 | 175 | 0 |
| K912855 | HAZEL | Kinetic Concepts, Inc. | 1991-09-06 | 70 | 0 |
| K905390 | KUDO (POWERED ROTATION BED) | Kinetic Concepts, Inc. | 1991-01-08 | 39 | 0 |
| K901901 | PROFILE, A CRITICAL CARE LOW AIR LOSS BED | Kinetic Concepts, Inc. | 1990-10-03 | 159 | 0 |
| K891151 | COOL 'N HEAT MACHINE | Kinetic Concepts, Inc. | 1989-04-06 | 34 | 0 |
| K891152 | GRAND COOLING MACHINE | Kinetic Concepts, Inc. | 1989-03-23 | 20 | 0 |
| K881917 | FLUIDAIR | Kinetic Concepts, Inc. | 1988-11-14 | 189 | 0 |
| K880340 | MODIFIED AIR FLUIDIZED BED, KINAIR | Kinetic Concepts, Inc. | 1988-02-16 | 21 | 0 |
| K875321 | MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE | Kinetic Concepts, Inc. | 1988-01-27 | 29 | 0 |
| K864232 | ROTATION AIR FLUIDIZED BED/DELTA | Kinetic Concepts, Inc. | 1986-12-16 | 49 | 0 |
| K851875 | KINNET | Kinetic Concepts, Inc. | 1985-08-22 | 115 | 0 |
| K851874 | OR TUBE RESTRAINT | Kinetic Concepts, Inc. | 1985-08-08 | 101 | 0 |
| K843781 | KINAIR, LOW AIR LOSS BED | Kinetic Concepts, Inc. | 1985-01-28 | 124 | 0 |
| K841542 | OMNIDIRECTIONAL POWERED WHEEL CHAIR | Kinetic Concepts, Inc. | 1984-05-11 | 25 | 0 |
| K833802 | INFANT WARMER | Kinetic Concepts, Inc. | 1984-04-05 | 156 | 0 |
| K834563 | EGERTON TURNING & TILTING BED | Kinetic Concepts, Inc. | 1984-01-30 | 33 | 0 |
| K832845 | EGERTON TURNING & TILTING NET SUSPEN BED | Kinetic Concepts, Inc. | 1983-11-28 | 98 | 0 |
| K823175 | SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER | Kinetic Concepts, Inc. | 1982-11-16 | 21 | 0 |
| K822402 | ROTO REST KINETIC TREATMENT TABLE PEDIA | Kinetic Concepts, Inc. | 1982-10-22 | 73 | 0 |
| K782002 | TRACH-COLLAR | Kinetic Concepts, Inc. | 1978-12-15 | 11 | 0 |
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