FDA product code KOX: Solvent, Adhesive Tape
KOX is the FDA product code for solvent, adhesive tape. It is a Class I device, regulated under 21 CFR 878.4730 and reviewed by the General and Plastic Surgery panel. FDA has cleared 12 510(k) submissions under KOX, from 11 different applicants. The average 510(k) review took 108 days (median 99). FDA has posted 3 recalls for KOX devices.
Classification
| Field | Value |
|---|---|
| Device name | Solvent, Adhesive Tape |
| Device class | Class I |
| Regulation | 21 CFR 878.4730 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KOX clearance
Top KOX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew United, Inc. | 2 | 1992-01-09 |
| Medi-Flex Hospital Products, Inc. | 1 | 1994-03-11 |
| Chad Labs Corp. | 1 | 1993-07-08 |
| Convatec, A Division of E.R. Squibb & Sons | 1 | 1993-04-20 |
| Orange-Sol, Inc. | 1 | 1993-04-06 |
6 more applicants have KOX clearances. See the full list in Caduvo.
Most recent KOX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934790 | Medi-Flex Hospital Products, Inc. | SEPP ADHESIVE REMOVER | 1994-03-11 | 157 |
| K931933 | Chad Labs Corp. | CHAD LABS ADHESIVE BANDAGE REMOVER | 1993-07-08 | 80 |
| K924976 | Convatec, A Division of E.R. Squibb & Sons | ALLKARE(TM) ADHESIVE REMOVER WIPE | 1993-04-20 | 201 |
| K924571 | Orange-Sol, Inc. | MEDI-SOL | 1993-04-06 | 208 |
| K925618 | 3M Health Care, Ltd. | 3M REMOVER LOTION PRODUCT NUMBER 86XX | 1993-03-31 | 145 |
Recalls for KOX devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-04-04.
Frequently asked questions
What is FDA product code KOX?
KOX is the FDA product code for solvent, adhesive tape. It is a Class I device, regulated under 21 CFR 878.4730 and reviewed by the General and Plastic Surgery panel.
What device class is KOX?
Class I, regulation 21 CFR 878.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KOX?
Across 12 cleared submissions the average was 108 days from receipt to decision (median 99).
Which companies have the most KOX clearances?
Smith & Nephew United, Inc. (2); Medi-Flex Hospital Products, Inc. (1); Chad Labs Corp. (1); Convatec, A Division of E.R. Squibb & Sons (1); Orange-Sol, Inc. (1).
Have KOX devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2011-04-04.
Next steps
- Run an FDA pathway report with predicate devices for product code KOX
- Run a recall and safety report across every KOX manufacturer
- Watch product code KOX 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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