Company ยท US
Kinetic Concepts, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2005. Name variants (Inc, Corp, punctuation) are merged.
48510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | 12 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 8 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 7 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 6 |
| IKZ | Bed, Patient Rotation, Powered | 5 |
| INX | Bed, Air Fluidized | 5 |
| JOW | Sleeve, Limb, Compressible | 5 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 4 |
| FTL | Mesh, Surgical, Polymeric | 2 |
| ILO | Pack, Hot Or Cold, Water Circulating | 2 |
| ITI | Wheelchair, Powered | 2 |
| CBH | Device, Fixation, Tracheal Tube | 1 |
| EQN | Laryngoscope, Nasopharyngoscope | 1 |
| FMT | Warmer, Infant Radiant | 1 |
| FNJ | Bed, Manual | 1 |
| INY | Bed, Patient Rotation, Manual | 1 |
| IRO | Vibrator, Therapeutic | 1 |
| NAD | Dressing, Wound, Occlusive | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 26, 2005 | K050261 | V.A.C. GRANUFOAM SILVER PROTECTION DRESSING Kinetic Concepts, Inc. | OMP |
| Jan 25, 2005 | K041642 | V.A.C. GRANUFOAM SILVER DRESSING Kinetic Concepts, Inc. | OMP |
| Oct 10, 2003 | K032310 | MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS Kinetic Concepts, Inc. | OMP |
| Feb 26, 2003 | K022011 | V.A.C. ABDOMINAL DRESSING Kinetic Concepts, Inc. | FTL |
| Dec 20, 2002 | K021500 | VACUUM ASSISTED CLOSURE Kinetic Concepts, Inc. | OMP |
| Dec 2, 2002 | K021501 | V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT Kinetic Concepts, Inc. | OMP |
| May 6, 2002 | K020781 | WET CHAMBER Kinetic Concepts, Inc. | NAD |
| Jan 18, 2000 | K992448 | V.A.C. PLUS Kinetic Concepts, Inc. | OMP |
| Jan 16, 1998 | K972176 | HOME CARE BEAD BED Kinetic Concepts, Inc. | INX |
| Nov 18, 1997 | K972549 | SIMPULSE Kinetic Concepts, Inc. | FNM |
| Oct 23, 1997 | K955243 | BARIAIR Kinetic Concepts, Inc. | FNM |
| Sep 5, 1997 | K970468 | KT AIR BED Kinetic Concepts, Inc. | FNM |
| Jul 18, 1997 | K954320 | MODIFIED PEDIKAIR Kinetic Concepts, Inc. | FNM |
| May 22, 1997 | K971548 | AMBUVAC Kinetic Concepts, Inc. | OMP |
| Mar 4, 1996 | K953850 | REDOX Kinetic Concepts, Inc. | JOW |
| Jun 21, 1995 | K944567 | COWBOY X Kinetic Concepts, Inc. | JOW |
| May 23, 1995 | K944094 | TRIADYNE Kinetic Concepts, Inc. | FNM |
| Mar 14, 1995 | K945062 | VACPLUS Kinetic Concepts, Inc. | JCX |
| Feb 16, 1995 | K945664 | BARIKARE PLUS Kinetic Concepts, Inc. | FNL |
| Nov 17, 1994 | K940886 | ANNELID Kinetic Concepts, Inc. | JCX |
| Mar 15, 1994 | K933402 | TURBO II Kinetic Concepts, Inc. | FNM |
| Oct 21, 1993 | K931581 | GLENN BED Kinetic Concepts, Inc. | FNL |
| Aug 2, 1993 | K930673 | PREMIUM Kinetic Concepts, Inc. | FNM |
| Jul 21, 1993 | K932215 | COWBOY III Kinetic Concepts, Inc. | JOW |
| Aug 24, 1992 | K920308 | COWBOY II Kinetic Concepts, Inc. | JOW |
| Apr 29, 1992 | K921768 | HAZEL II Kinetic Concepts, Inc. | IOQ |
| Jan 13, 1992 | K913611 | COWBOY Kinetic Concepts, Inc. | JOW |
| Jan 8, 1992 | K913998 | PAM PLUS Kinetic Concepts, Inc. | IRO |
| Dec 20, 1991 | K912854 | TURBO Kinetic Concepts, Inc. | IOQ |
| Sep 6, 1991 | K912855 | HAZEL Kinetic Concepts, Inc. | IOQ |
| Jan 8, 1991 | K905390 | KUDO (POWERED ROTATION BED) Kinetic Concepts, Inc. | IKZ |
| Oct 3, 1990 | K901901 | PROFILE, A CRITICAL CARE LOW AIR LOSS BED Kinetic Concepts, Inc. | FNM |
| Apr 6, 1989 | K891151 | COOL 'N HEAT MACHINE Kinetic Concepts, Inc. | ILO |
| Mar 23, 1989 | K891152 | GRAND COOLING MACHINE Kinetic Concepts, Inc. | ILO |
| Nov 14, 1988 | K881917 | FLUIDAIR Kinetic Concepts, Inc. | INX |
| Feb 16, 1988 | K880340 | MODIFIED AIR FLUIDIZED BED, KINAIR Kinetic Concepts, Inc. | INX |
| Jan 27, 1988 | K875321 | MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE Kinetic Concepts, Inc. | IOQ |
| Dec 16, 1986 | K864232 | ROTATION AIR FLUIDIZED BED/DELTA Kinetic Concepts, Inc. | IOQ |
| Aug 22, 1985 | K851875 | KINNET Kinetic Concepts, Inc. | INY |
| Aug 8, 1985 | K851874 | OR TUBE RESTRAINT Kinetic Concepts, Inc. | CBH |
| Jan 28, 1985 | K843781 | KINAIR, LOW AIR LOSS BED Kinetic Concepts, Inc. | FNL |
| May 11, 1984 | K841542 | OMNIDIRECTIONAL POWERED WHEEL CHAIR Kinetic Concepts, Inc. | ITI |
| Apr 5, 1984 | K833802 | INFANT WARMER Kinetic Concepts, Inc. | FMT |
| Jan 30, 1984 | K834563 | EGERTON TURNING & TILTING BED Kinetic Concepts, Inc. | IKZ |
| Nov 28, 1983 | K832845 | EGERTON TURNING & TILTING NET SUSPEN BED Kinetic Concepts, Inc. | FNJ |
| Nov 16, 1982 | K823175 | SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER Kinetic Concepts, Inc. | ITI |
| Oct 22, 1982 | K822402 | ROTO REST KINETIC TREATMENT TABLE PEDIA Kinetic Concepts, Inc. | IKZ |
| Dec 15, 1978 | K782002 | TRACH-COLLAR Kinetic Concepts, Inc. | EQN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2006 | Kinetic Concepts, Inc Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5***Manufact Terminated |
FTL | K022011 |
| Feb 14, 2006 | Kinetic Concepts, Inc RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX. Terminated |
IKZ | None listed |
| Jan 11, 2006 | Kinetic Concepts, Inc V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE. Terminated |
JCX | K032310 |
| Nov 8, 2005 | Kinetic Concepts, Inc Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call Toll Free 1-800-531-5346, FAX (210) 308-399 Terminated |
FNL | None listed |
| Mar 10, 2005 | Kinetic Concepts, Inc KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas Terminated |
IOQ | K970468 |
| Oct 22, 2004 | Kinetic Concepts, Inc V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230 Terminated |
JCX | K032310 |
| Jul 20, 2004 | Kinetic Concepts, Inc KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189 Terminated |
IOQ | None listed |
| Jul 20, 2004 | Kinetic Concepts, Inc Burke Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX, model number 7064 Terminated |
FNL | None listed |
| Jul 20, 2004 | Kinetic Concepts, Inc KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080 Terminated |
INX | None listed |
| Jul 20, 2004 | Kinetic Concepts, Inc KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900 Terminated |
IKZ | None listed |
| Apr 18, 2003 | Kinetic Concepts, Inc TransportAir Auxiliary Blower Unit. Terminated |
IOQ | None listed |
| Apr 18, 2003 | Kinetic Concepts, Inc PediDyne AC-Powered Adjustable Hospital Beds Terminated |
IOQ | None listed |
| Apr 18, 2003 | Kinetic Concepts, Inc BariAir AC-Powered Adjustable Hospital Beds Terminated |
IOQ | None listed |
| Apr 18, 2003 | Kinetic Concepts, Inc KinAir IV TheraPulse II AC-Powered Adjustable Hospital Beds Terminated |
IOQ | None listed |
| Apr 18, 2003 | Kinetic Concepts, Inc TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds Terminated |
IOQ | None listed |
| Apr 10, 2003 | Kinetic Concepts, Inc TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit, manufactured by Kinetic Concepts, Inc. Terminated |
INX | None listed |
| Jan 9, 2003 | Kinetic Concepts, Inc KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas Terminated |
FNL | K955243 |