510(k) · Cleared
ClearedHM Surgical Drapes HM Surgical Equipment Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Holymed Products Co., Ltd. · KKX Drape, Surgical, Antimicrobial
Cleared on Dec 12, 2012 after a 156-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 12, 2012
- Review
- 156 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KKX device
- #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KKX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KKX
182in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKX
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KKX
24in 2025
MAUDE reports naming product code KKX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 181 | 1 | 24 |
| 2008 | 5 | 164 | 0 | 24 |
| 2009 | 5 | 114 | 0 | 27 |
| 2010 | 8 | 107 | 1 | 25 |
| 2011 | 4 | 147 | 1 | 57 |
| 2012 | 2 | — | 1 | 40 |
| 2013 | 3 | 227 | 7 | 63 |
| 2014 | 6 | 182 | 7 (7) | 28 |
| 2015 | 2 | — | 0 | 33 |
| 2016 | 0 | — | 4 | 56 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 2 | — | 0 | 32 |
| 2024 | 0 | — | 2 | 19 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. HM surgical drapes ame disposable, single use, sterile or nonsterile. Non-sterile HIM surgical drapes are to be sold to repackagerlrelabeler establishments for Eta sterilization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization…
Read the full statement (152 words)
HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
HM surgical drapes ame disposable, single use, sterile or nonsterile.
Non-sterile HIM surgical drapes are to be sold to repackagerlrelabeler establishments for Eta sterilization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Drapes am provided as below
HM Surgical Equipment Covers are intended to be used to cover surgical equipment and provide a protective bordler for that equipment
HM surgical equipment cavern are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical equipment covers are to be sold to repackager/relabeler establishments for EtO sterilization accrding to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO steriiztion validation to 180 11135-1.
Drape are provided as below
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K122000 · printed Nov 3, 2026
Cite this page
510(k) Report. “K122000: HM Surgical Drapes HM Surgical Equipment Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K122000
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026