FDA product code INX: Bed, Air Fluidized
INX is the FDA product code for bed, air fluidized. It is a Class II device, regulated under 21 CFR 890.5160 and reviewed by the Physical Medicine panel. FDA has cleared 28 510(k) submissions under INX, from 23 different applicants. The average 510(k) review took 106 days (median 69). FDA has posted 9 recalls for INX devices.
Classification
| Field | Value |
|---|---|
| Device name | Bed, Air Fluidized |
| Device class | Class II |
| Regulation | 21 CFR 890.5160 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every INX clearance
Top INX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Concepts, Inc. | 3 | 1998-01-16 |
| Ssi Medical Services, Inc. | 3 | 1995-02-27 |
| Uhi Corp. | 2 | 1984-09-05 |
| Hill-Rom, Inc. | 1 | 1997-05-28 |
| American Life Support Technology, Inc. | 1 | 1994-02-17 |
18 more applicants have INX clearances. See the full list in Caduvo.
Most recent INX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972176 | Kinetic Concepts, Inc. | HOME CARE BEAD BED | 1998-01-16 | 221 |
| K964223 | Hill-Rom, Inc. | CLINITRON RITE-HITE | 1997-05-28 | 217 |
| K943385 | Ssi Medical Services, Inc. | CLINITRON ELEXIS | 1995-02-27 | 229 |
| K942184 | Ssi Medical Services, Inc. | CLINITRON AT HOME AIR FLUIDED THERAPY | 1995-02-07 | 279 |
| K931168 | American Life Support Technology, Inc. | X-20 AIR SUPPORT BED | 1994-02-17 | 346 |
Recalls for INX devices
9 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-02-03.
Frequently asked questions
What is FDA product code INX?
INX is the FDA product code for bed, air fluidized. It is a Class II device, regulated under 21 CFR 890.5160 and reviewed by the Physical Medicine panel.
What device class is INX?
Class II, regulation 21 CFR 890.5160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INX?
Across 28 cleared submissions the average was 106 days from receipt to decision (median 69).
Which companies have the most INX clearances?
Kinetic Concepts, Inc. (3); Ssi Medical Services, Inc. (3); Uhi Corp. (2); Hill-Rom, Inc. (1); American Life Support Technology, Inc. (1).
Have INX devices been recalled?
Yes: 9 product recalls across 6 recall events; the most recent began 2012-02-03.
Next steps
- Run an FDA pathway report with predicate devices for product code INX
- Run a recall and safety report across every INX manufacturer
- Watch product code INX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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