FDA product code ILS: Adaptor, Hygiene
ILS is the FDA product code for adaptor, hygiene. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel. FDA has cleared 31 510(k) submissions under ILS, from 10 different applicants. The average 510(k) review took 24 days (median 17). FDA has posted 4 recalls for ILS devices.
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Hygiene |
| 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 ILS clearance
Top ILS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 17 | 1983-06-08 |
| Maddak, Inc. | 3 | 1983-05-09 |
| Guardian Products Co., Inc. | 2 | 1984-08-07 |
| Lic-Orthion | 2 | 1983-06-08 |
| Orthion Corp. | 2 | 1982-11-05 |
5 more applicants have ILS clearances. See the full list in Caduvo.
Most recent ILS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K852049 | Pedro Aleman | MEDICAL TOILET SEAT | 1985-06-24 | 47 |
| K842651 | Guardian Products Co., Inc. | COMMODE CHAIR 98200 | 1984-08-07 | 28 |
| K830853 | Lic-Orthion | LAVATORY SEAT HEIGHTENER | 1983-06-08 | 83 |
| K831547 | Fred Sammons, Inc. | RAISED TOILET SEATS & NAIL CLIPPERS | 1983-06-08 | 27 |
| K830425 | Maddak, Inc. | TOILET SEAT RAISED | 1983-05-09 | 89 |
Recalls for ILS devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-03-24.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code ILS?
ILS is the FDA product code for adaptor, hygiene. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel.
What device class is ILS?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILS?
Across 31 cleared submissions the average was 24 days from receipt to decision (median 17).
Which companies have the most ILS clearances?
Fred Sammons, Inc. (17); Maddak, Inc. (3); Guardian Products Co., Inc. (2); Lic-Orthion (2); Orthion Corp. (2).
Have ILS devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2021-03-24.
Next steps
- Run an FDA pathway report with predicate devices for product code ILS
- Run a recall and safety report across every ILS manufacturer
- Watch product code ILS 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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