510(k) · Cleared
ClearedNext Generation Infused (R) or Towel (Hemed), Next Generation Infused (R) or Towel (with Binding) Model HUCKCR17X27MH, H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hinson and Hale Medical Technologies, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Nov 19, 2010 after a 325-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 19, 2010
- Review
- 325 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. 2010, 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?
The Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towels, made of synthetic material, both hemmed (Model Number HUCKCR17X27MH) and with binding (Model Number HUCKCR I7X27WB), are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The OR towels are further used as a fluid absorbing towel during surgery or as a device to dry the hands of OR…
Read the full statement (134 words)
The Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towels, made of synthetic material, both hemmed (Model Number HUCKCR17X27MH) and with binding (Model Number HUCKCR I7X27WB), are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The OR towels are further used as a fluid absorbing towel during surgery or as a device to dry the hands of OR personnel. These towels are provided non-sterile and must be processed before use. These towels may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum sterilizer, 2700 F, 4 minutes with 20 minutes drying time).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K094016 · printed Nov 4, 2026
Cite this page
510(k) Report. “K094016: Next Generation Infused (R) or Towel (Hemed), Next Generation Infused (R) or Towel (with Binding) Model HUCKCR17X27MH, H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K094016
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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