KOX
12 FDA 510(k) clearances · Product code
118 daysmedian time to decision
201 days90th percentile
12clearances measured
FDA profile
- Official device name
- Solvent, Adhesive Tape
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4730
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1999: 2 · 2006: 4 · 2011: 17 · 2020: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SEPP ADHESIVE REMOVER (K934790) | Medi-Flex Hospital Products, Inc. | 1994-03-11 |
| CHAD LABS ADHESIVE BANDAGE REMOVER (K931933) | Chad Labs Corp. | 1993-07-08 |
| ALLKARE(TM) ADHESIVE REMOVER WIPE (K924976) | Convatec, A Division of E.R. Squibb & Sons | 1993-04-20 |
| MEDI-SOL (K924571) | Orange-Sol, Inc. | 1993-04-06 |
| 3M REMOVER LOTION PRODUCT NUMBER 86XX (K925618) | 3M Health Care, Ltd. | 1993-03-31 |
| SKIN SUPPORT PREP PAD (K923351) | Coloplast Corp. | 1992-09-14 |
| REMOVE ADHESIVE REMOVER (K915150) | Smith & Nephew United, Inc. | 1992-01-09 |
| ELANTEC'S SURGICAL TAPE REMOVER (K902009) | Elantec, Inc. | 1990-08-29 |
| KEMI LABS - ADHESIVE BANDAGE REMOVER (K895293) | Kemi Labs, Inc. | 1990-02-09 |
| REMOVE ADHESIVE REMOVER (K893603) | Smith & Nephew United, Inc. | 1989-07-14 |
| DECALCIFYING SOLUTION II (K881359) | Stephens Scientific | 1988-04-19 |
| ADHESIVE REMOVER (K821162) | The Healthcare Group Laboratories, Inc. | 1982-05-14 |
Track KOX automatically
Every clearance here is in the API, with alerts when new ones post.