FDA product code IKX: Aid, Transfer
IKX is the FDA product code for aid, transfer. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel. FDA has cleared 18 510(k) submissions under IKX, from 8 different applicants. The average 510(k) review took 21 days (median 19). FDA has posted 20 recalls for IKX devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Aid, Transfer |
| Device class | Class I |
| Regulation | 21 CFR 890.5050 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IKX clearance
Top IKX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 8 | 1983-06-02 |
| Guardian Products Co., Inc. | 2 | 1984-08-10 |
| Orthion Corp. | 2 | 1982-11-05 |
| Maddak, Inc. | 2 | 1981-09-14 |
| Mednet, Inc. | 1 | 1986-08-13 |
3 more applicants have IKX clearances. See the full list in Caduvo.
Most recent IKX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K862895 | Mednet, Inc. | TRICYCLES | 1986-08-13 | 22 |
| K842650 | Guardian Products Co., Inc. | WALL GRAB BARS 98130-98136 | 1984-08-10 | 31 |
| K831541 | Fred Sammons, Inc. | TUB TRANSFER BENCH BK6481 | 1983-06-02 | 21 |
| K823640 | Fred Sammons, Inc. | BATH TUB SAFETY BAR | 1983-01-21 | 46 |
| K823639 | Fred Sammons, Inc. | BOARD TO TRANSFER PARALYZED PATIENT FROM | 1983-01-21 | 46 |
Recalls for IKX devices
20 product recalls in 10 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2024-11-05.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2020 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code IKX?
IKX is the FDA product code for aid, transfer. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel.
What device class is IKX?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IKX?
Across 18 cleared submissions the average was 21 days from receipt to decision (median 19).
Which companies have the most IKX clearances?
Fred Sammons, Inc. (8); Guardian Products Co., Inc. (2); Orthion Corp. (2); Maddak, Inc. (2); Mednet, Inc. (1).
Have IKX devices been recalled?
Yes: 20 product recalls across 10 recall events; the most recent began 2024-11-05.
Next steps
- Run an FDA pathway report with predicate devices for product code IKX
- Run a recall and safety report across every IKX manufacturer
- Watch product code IKX 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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