FDA product code · General, Plastic Surgery
KKXDrape, Surgical, Antimicrobial
Product code KKX covers Drape, Surgical, Antimicrobial, a Class II device regulated under 21 CFR 878.4370. FDA has cleared 450 devices in this code. Median review time across the 450 most recent decisions is 73 days. openFDA lists 91 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 878.4370
- Review panel
- General, Plastic Surgery
- Clearances
- 450
What is happening in KKX right now?
KKX (Drape, Surgical, Antimicrobial) has two findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1889-2026, Z-1409-2026, Z-2124-2026). The code is crowded, scoring 60 of 100 — 249 companies hold a clearance here and 0 arrived in the last 12 months (KKX:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1889-2026, Z-1409-2026, Z-2124-2026 |
| Crowding | Context | KKX:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code KKX cover?
KKX is FDA's product code for Drape, Surgical, Antimicrobial, a Class II device regulated under 21 CFR 878.4370.
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.
Source: openFDA device/classification · record KKX · retrieved
How many devices has FDA cleared in KKX?
FDA has cleared 450 devices under product code KKX since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. | |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company | |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | Avery Dennison Belgie Bvba | |
| K200238 | ControlRad Sterile Cover | Controlrad, Inc. | |
| K163556 | MediClear PreOp | Covalontechnologies, Inc. | |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | |
| K140195 | SURGICAL DRAPE | Griffith-Lucas, LLC | |
| K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | 3M Healthcare | |
| K141438 | WHITNEY MEDICAL SOLUTIONS ESHIELD | Whitney Medical Solutions |
How long does FDA review take for KKX?
The median FDA review time for KKX is 73 days, measured across the 450 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KKX?
openFDA lists 91 recall records against product code KKX. A recall record covers one firm's corrective action and may span many device lots.
Z-1889-2026Open, ClassifiedMedline Industries, LP
Unapproved design changes to the products outside of the 510(k) clearance.
Z-1409-2026Open, ClassifiedMedline Industries, LP
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2124-2026Open, ClassifiedMedline Industries, LP
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2520-2025Open, ClassifiedO&M Halyard, Inc.
Surgical drape packs may have open seals, which may compromise the sterility of the product.
Z-1608-2025Open, ClassifiedMEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Showing the 5 most recently initiated of 91. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KKX?
MAUDE holds 69 adverse-event reports naming product code KKX, 9 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KKX unusual?
Every month with enough history behind it falls inside KKX's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 2 | 0–5 | Within expected (0–5) | |
| 1 | 0–5 | Within expected (0–5) | |
| 1 | 0–5 | Within expected (0–5) | |
| 2 | 0–6 | Within expected (0–6) | |
| 2 | 0–5 | Within expected (0–5) | |
| 3 | 0–5 | Within expected (0–5) | |
| 2 | 0–5 | Within expected (0–5) | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
23 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in KKX.
What are the predicate devices in KKX?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KKX?
Across the 450 most recent decisions, these applicants filed most often in KKX.
| Applicant | Recent clearances |
|---|---|
| Surgikos, Inc. | 30 |
| Procter & Gamble Mfg. Co. | 14 |
| Customed, Inc. | 11 |
| Deroyal Industries, Inc. | 11 |
| Allegiance Healthcare Corp. | 9 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch KKX
Get an email the morning anything changes in KKX — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.