FDA product code KIC: Cushion, Flotation
KIC is the FDA product code for cushion, flotation. It is a Class I device, regulated under 21 CFR 890.3175 and reviewed by the Physical Medicine panel. FDA has cleared 29 510(k) submissions under KIC, from 23 different applicants. The average 510(k) review took 45 days (median 27). FDA has posted 1 recall for KIC devices.
Classification
| Field | Value |
|---|---|
| Device name | Cushion, Flotation |
| Device class | Class I |
| Regulation | 21 CFR 890.3175 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIC clearance
Top KIC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Span-America Medical Systems, Inc. | 2 | 1996-02-07 |
| Steridyne Corp. | 2 | 1991-05-30 |
| D.A. Schulman, Inc. | 2 | 1987-07-30 |
| Medical Industries America, Inc. | 2 | 1986-11-14 |
| Jay Medical, Ltd. | 2 | 1986-03-10 |
18 more applicants have KIC clearances. See the full list in Caduvo.
Most recent KIC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960189 | Span-America Medical Systems, Inc. | GEL-T CUSHION | 1996-02-07 | 22 |
| K953352 | Iskra.Med | PROTEAM CUSHION | 1995-11-29 | 135 |
| K954117 | Span-America Medical Systems, Inc. | CUSTOMCARE SEATING SYSTEM | 1995-10-13 | 42 |
| K950085 | Multigestion (Deutschland) GmbH | MULTICURE(R) S GEL PAD | 1995-07-13 | 184 |
| K945667 | Micos Medical Systems | MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION | 1995-02-21 | 96 |
Recalls for KIC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-03-20.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code KIC?
KIC is the FDA product code for cushion, flotation. It is a Class I device, regulated under 21 CFR 890.3175 and reviewed by the Physical Medicine panel.
What device class is KIC?
Class I, regulation 21 CFR 890.3175. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIC?
Across 29 cleared submissions the average was 45 days from receipt to decision (median 27).
Which companies have the most KIC clearances?
Span-America Medical Systems, Inc. (2); Steridyne Corp. (2); D.A. Schulman, Inc. (2); Medical Industries America, Inc. (2); Jay Medical, Ltd. (2).
Have KIC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-03-20.
Next steps
- Run an FDA pathway report with predicate devices for product code KIC
- Run a recall and safety report across every KIC manufacturer
- Watch product code KIC 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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