FDA product code KGX: Tape And Bandage, Adhesive
KGX is the FDA product code for tape and bandage, adhesive. It is a Class I device, regulated under 21 CFR 880.5240 and reviewed by the General and Plastic Surgery panel. FDA has cleared 187 510(k) submissions under KGX, from 108 different applicants. The average 510(k) review took 112 days (median 84). FDA has posted 48 recalls for KGX devices, 16 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tape And Bandage, Adhesive |
| Device class | Class I |
| Regulation | 21 CFR 880.5240 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Top KGX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beiersdorf, Inc. | 15 | 1994-07-29 |
| Lectec Corp. | 8 | 1993-04-21 |
| Convatec, A Division of E.R. Squibb & Sons | 6 | 1994-03-01 |
| Smith & Nephew United, Inc. | 6 | 1992-09-15 |
| 3M Company | 6 | 1990-08-08 |
103 more applicants have KGX clearances. See the full list in Caduvo.
Most recent KGX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001240 | Platinum Services, Inc. | SERAGARD INJECTION PATCH | 2000-06-21 | 64 |
| K983368 | Aso Corp. | CARE BAND ANTIBACTERIAL BANDAGES | 1999-02-17 | 146 |
| K972914 | Marine Polymer Technologies, Inc. | SYVEK PATCH | 1997-12-22 | 137 |
| K943314 | Johnson & Johnson Consumer Products, Inc. | ADHESIVE BANDAGES WITH OTC DRUG | 1996-01-17 | 555 |
| K952606 | Cutting Edge Technologies, Inc. | TARGETT PATCH | 1995-12-21 | 198 |
Recalls for KGX devices
48 product recalls in 22 recall events; 16 initiated in the last five years and 16 still open. Most recent: 2025-12-26.
| Year | Recalls |
|---|---|
| 2017 | 9 |
| 2019 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 4 |
| 2025 | 9 |
Frequently asked questions
What is FDA product code KGX?
KGX is the FDA product code for tape and bandage, adhesive. It is a Class I device, regulated under 21 CFR 880.5240 and reviewed by the General and Plastic Surgery panel.
What device class is KGX?
Class I, regulation 21 CFR 880.5240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KGX?
Across 187 cleared submissions the average was 112 days from receipt to decision (median 84).
Which companies have the most KGX clearances?
Beiersdorf, Inc. (15); Lectec Corp. (8); Convatec, A Division of E.R. Squibb & Sons (6); Smith & Nephew United, Inc. (6); 3M Company (6).
Have KGX devices been recalled?
Yes: 48 product recalls across 22 recall events; the most recent began 2025-12-26.
Next steps
- Run an FDA pathway report with predicate devices for product code KGX
- Run a recall and safety report across every KGX manufacturer
- Watch product code KGX 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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