CLINITRON C-II
FDA 510(k) clearance K920112 · decided 1992-01-24
Clearance details
- K-number
- K920112
- Device name
- CLINITRON C-II
- Applicant
- Support Systems Intl.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-10
- Decision date
- 1992-01-24
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- INX
- Device class
- 2
- Regulation number
- 890.5160
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HOME CARE BEAD BED (K972176) | Kinetic Concepts, Inc. | 1998-01-16 |
| CLINITRON RITE-HITE (K964223) | Hill-Rom, Inc. | 1997-05-28 |
| CLINITRON ELEXIS (K943385) | Ssi Medical Services, Inc. | 1995-02-27 |
| CLINITRON AT HOME AIR FLUIDED THERAPY (K942184) | Ssi Medical Services, Inc. | 1995-02-07 |
| X-20 AIR SUPPORT BED (K931168) | American Life Support Technology, Inc. | 1994-02-17 |
| LOW AIR LOSS MATTRESS, MODIFICATION (K934689) | Cardio Systems, Inc. | 1994-02-02 |
| DYLNAMEDICS A.S.A.P. (K924973) | Dynamedics, Inc. | 1993-10-15 |
| COMFORT CARE LOW AIR LOSS THERAPY BED (K926402) | Ch Administration, Inc. | 1993-03-24 |
| REM-AIR (K924686) | Mellenair Ent., Inc. | 1993-02-12 |
| SMITH AND DAVIS PRESSURE THERAPY SYSTEM (K913654) | Smith & Davis Mfg. Co. | 1991-11-22 |
| THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 (K911246) | The Medical Group, Inc. | 1991-06-06 |
| DERMATEK 4000 (K911057) | Anacom General Corp. | 1991-04-05 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CLINITRON UP-LIFT" Air Fluidized Therapy Units. Intended to prevent and/or treat pressure recall (Z-1903-2009) | Hill-Rom Manufacturing, Inc. | 2009-08-25 |
| CLINITRON UP-LIFT Air Fluidized Therapy unit. recall (Z-0990-03) | Hill-Rom Manufacturing, Inc. | 2003-07-10 |