CLINITRON AIR FLUIDIZED SUPPORT SYSTEM
FDA 510(k) clearance K813584 · decided 1982-01-12
Clearance details
- K-number
- K813584
- Device name
- CLINITRON AIR FLUIDIZED SUPPORT SYSTEM
- Applicant
- Uhi Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-28
- Decision date
- 1982-01-12
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- INX
- Device class
- 2
- Regulation number
- 890.5160
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Uhi Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| CLINITRON C-II (K920112) | Support Systems Intl. | 1992-01-24 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer recall (Z-1902-2009) | Hill-Rom Manufacturing, Inc. | 2009-08-25 |
| CLINITRON CII Air Fluidized Therapy unit. recall (Z-0989-03) | Hill-Rom Manufacturing, Inc. | 2003-07-10 |