FDA product code KKX: Drape, Surgical, Antimicrobial
KKX is the FDA product code for drape, surgical, antimicrobial. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel. FDA has cleared 450 510(k) submissions under KKX, 2 in the last five years, from 252 different applicants. The average 510(k) review took 109 days (median 73). FDA has posted 91 recalls for KKX devices, 11 initiated in the last five years.
Definition
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
Classification
| Field | Value |
|---|---|
| Device name | Drape, Surgical, Antimicrobial |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KKX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 269 |
| 2020 | 1 | 86 |
| 2021 | 1 | 358 |
| 2023 | 2 | 248 |
Compare with all 510(k) review times · Search every KKX clearance
Top KKX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgikos, Inc. | 30 | 1982-07-22 |
| Procter & Gamble Mfg. Co. | 14 | 1985-01-14 |
| Deroyal Industries, Inc. | 11 | 2003-04-29 |
| Customed, Inc. | 11 | 1998-01-05 |
| Allegiance Healthcare Corp. | 9 | 2003-02-11 |
247 more applicants have KKX clearances. See the full list in Caduvo.
Most recent KKX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230645 | Avery Dennison Medical , Ltd. | BeneHold Surgical Incise Drape with CHG antimicrobial II | 2023-10-25 | 231 |
| K222578 | 3M Company | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 2023-05-18 | 266 |
| K202208 | Avery Dennison Belgie Bvba | BeneHold Surgical Incise Drape with CHG antimicrobial | 2021-07-30 | 358 |
| K200238 | Controlrad, Inc. | ControlRad Sterile Cover | 2020-04-26 | 86 |
| K163556 | Covalontechnologies, Inc. | MediClear PreOp | 2017-09-14 | 269 |
Recalls for KKX devices
91 product recalls in 39 recall events; 11 initiated in the last five years and 11 still open. Most recent: 2026-02-27.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code KKX?
KKX is the FDA product code for drape, surgical, antimicrobial. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel.
What device class is KKX?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k).
How long does a 510(k) take for product code KKX?
Across 450 cleared submissions the average was 109 days from receipt to decision (median 73).
Which companies have the most KKX clearances?
Surgikos, Inc. (30); Procter & Gamble Mfg. Co. (14); Deroyal Industries, Inc. (11); Customed, Inc. (11); Allegiance Healthcare Corp. (9).
Have KKX devices been recalled?
Yes: 91 product recalls across 39 recall events; the most recent began 2026-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code KKX
- Run a recall and safety report across every KKX manufacturer
- Watch product code KKX 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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