BARIAIR
FDA 510(k) clearance K955243 · decided 1997-10-23
Clearance details
- K-number
- K955243
- Device name
- BARIAIR
- Applicant
- Kinetic Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-15
- Decision date
- 1997-10-23
- Days to decision
- 708 days
- Clearance type
- Traditional
- Product code
- FNM
- Device class
- 2
- Regulation number
- 880.5550
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kinetic Concepts
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 |
|---|---|---|
| PRESSURE GUARD SITE SELECT (A) (K973169) | Span-America Medical Systems, Inc. | 1998-02-20 |
| ZAK-2000 (K972022) | Cardio Systems, Inc. | 1998-01-22 |
| MIGHTY AIR (K974319) | Wheelchairs of Kansas | 1998-01-22 |
| PHYSIO/1000 (K974070) | Physio Designs, Inc. | 1998-01-06 |
| SIMPULSE (K972549) | Kinetic Concepts, Inc. | 1997-11-18 |
| SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM (K970081) | Cathay Consolidated, Inc. | 1997-11-07 |
| KT AIR BED (K970468) | Kinetic Concepts, Inc. | 1997-09-05 |
| RID-DECUBE II (K965207) | Skin Care Management, Inc. | 1997-08-21 |
| ALTERNATING PRESSURE AIR FLOTATION MATTRESS (K972153) | Decubiti Concepts, Inc. | 1997-07-31 |
| REST MATTRESS (K971568) | Rest Mattress | 1997-07-18 |
| MODIFIED PEDIKAIR (K954320) | Kinetic Concepts, Inc. | 1997-07-18 |
| CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM (K970362) | Apex Metal, Inc. | 1997-05-16 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufacture recall (Z-0414-03) | Kinetic Concepts, Inc | 2003-01-09 |