FDA product code IKY: Mattress, Flotation Therapy, Non-Powered
IKY is the FDA product code for mattress, flotation therapy, non-powered. It is a Class I device, regulated under 21 CFR 880.5150 and reviewed by the General Hospital panel. FDA has cleared 8 510(k) submissions under IKY, from 6 different applicants. The average 510(k) review took 34 days (median 22). FDA has posted 11 recalls for IKY devices.
Classification
| Field | Value |
|---|---|
| Device name | Mattress, Flotation Therapy, Non-Powered |
| Device class | Class I |
| Regulation | 21 CFR 880.5150 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IKY clearance
Top IKY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jefferson Industries, Inc. | 2 | 1981-12-02 |
| Medpro, Inc. | 2 | 1977-11-15 |
| Gaymar Industries, Inc. | 1 | 1992-03-12 |
| Leemart Bedding Mfg. Co. | 1 | 1980-12-10 |
| Tetra Group U.S.A., Inc. | 1 | 1980-12-10 |
1 more applicants have IKY clearances. See the full list in Caduvo.
Most recent IKY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914921 | Gaymar Industries, Inc. | SCM-3 AND ACCESSORIES | 1992-03-12 | 129 |
| K813226 | Jefferson Industries, Inc. | GEL FLOTATION MATTRESS | 1981-12-02 | 22 |
| K802781 | Leemart Bedding Mfg. Co. | BEDDING PADS EGGCREATE PADS | 1980-12-10 | 35 |
| K802833 | Tetra Group U.S.A., Inc. | TETRA NATAL-MAT WATER FLOTATION MAT. | 1980-12-10 | 28 |
| K780779 | Jefferson Industries, Inc. | ECONO-FLOAT WATER FLOTATION MATTRESS | 1978-05-19 | 8 |
Recalls for IKY devices
11 product recalls in 8 recall events; 0 initiated in the last five years and 4 still open. Most recent: 2021-05-12.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2020 | 2 |
| 2021 | 4 |
Frequently asked questions
What is FDA product code IKY?
IKY is the FDA product code for mattress, flotation therapy, non-powered. It is a Class I device, regulated under 21 CFR 880.5150 and reviewed by the General Hospital panel.
What device class is IKY?
Class I, regulation 21 CFR 880.5150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IKY?
Across 8 cleared submissions the average was 34 days from receipt to decision (median 22).
Which companies have the most IKY clearances?
Jefferson Industries, Inc. (2); Medpro, Inc. (2); Gaymar Industries, Inc. (1); Leemart Bedding Mfg. Co. (1); Tetra Group U.S.A., Inc. (1).
Have IKY devices been recalled?
Yes: 11 product recalls across 8 recall events; the most recent began 2021-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code IKY
- Run a recall and safety report across every IKY manufacturer
- Watch product code IKY 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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