510(k) · Cleared
Recalled · Class II · 2015Microtek Equipment Drapes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microtek Medical, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on May 17, 2005 as substantially equivalent to K032065 (Medline Industries, Inc., 2003) and 1 other predicate after a 97-day review. Its family tree reaches back 1 generation to 1995. 9 later devices descend from it. It has been recalled 17 times.
- Decided
- May 17, 2005
- Review
- 97 days
- Class
- Class II
- Product code
- KKX
- Recalls
- 17
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931417 (1995). 2 ancestors in all. 9 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK931417 Sterile Equipment CoversCustom Medical Products, Ltd. · 1995
- This deviceK050322 Microtek Equipment DrapesMicrotek Medical, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK081476 Surgical Concept Designs Positionor Surgical DrapeSurgical Concept Designs · 2008
- Descendant · cites it directly · 1 of its ownK052395 Sterile Equipment CoversVolcano Corporation · 2005 · Recalled
- Descendant · cites it directly · 0 of its ownK141438 Whitney Medical Solutions EshieldWhitney Medical Solutions · 2014
- Descendant · 2 generations on · 0 of its ownK131096 AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · cites it directly2descendants
- K081476Surgical Concept Designs Positionor Surgical DrapeSurgical Concept Designs · 2008 · cites it directly1descendant
- K052395Sterile Equipment CoversVolcano Corporation · 2005 · cites it directly1descendant
- K141438Whitney Medical Solutions EshieldWhitney Medical Solutions · 2014 · cites it directly0descendants
- K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931417 | Sterile Equipment Covers | Custom Medical Products, Ltd. | 1995 | — |
| 0 (this device) | K050322 | Microtek Equipment Drapes | Microtek Medical, Inc. | 2005 | — |
| +1 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
| +1 | K081476 | Surgical Concept Designs Positionor Surgical Drape | Surgical Concept Designs | 2008 | — |
| +1 | K052395 | Sterile Equipment Covers | Volcano Corporation | 2005 | 2 |
| +1 | K141438 | Whitney Medical Solutions Eshield | Whitney Medical Solutions | 2014 | — |
| +2 | K131096 | AR1000 Series Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032065 | Medline Band Bags and Equipment CoversSummary page 1…ification: II Statement of Substantial Equivalence Microtek Medical, Inc. Equipment Drapes are equivalent to: 1. Medline band Bags and Equipment Drapes - K032065 2. Custom Medical Products Equipment Drapes - K931417 Description of Device The Microtek Equipment Drapes consist of pol… | 2003 |
| * | K931417 | Sterile Equipment CoversSummary page 1…crotek Medical, Inc. Equipment Drapes are equivalent to: 1. Medline band Bags and Equipment Drapes - K032065 2. Custom Medical Products Equipment Drapes - K931417 Description of Device The Microtek Equipment Drapes consist of poly film and non-woven material, separately and in combination,… | 1995 |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | 2011 | 2 |
| K081476 | Surgical Concept Designs Positionor Surgical Drape | 2008 | 1 |
| K052395 | Sterile Equipment Covers | 2005 | 1 |
| K141438 | Whitney Medical Solutions Eshield | 2014 | 0 |
| K123980 | Sonicone Plus Ultrasound Wound Care System and Accessories | 2013 | 0 |
| K052668 | OR Specific Big Case Back Table Cover | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2015 | Class II | Z-1385-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1387-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1382-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1389-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1391-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1381-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1386-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1388-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1383-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1384-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1393-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1380-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1390-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Mar 16, 2015 | Class II | Z-1392-2015 | Packaging process control | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Jul 19, 2013 | Class II | Z-1995-2013 | Package design/selection | Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier… |
| Aug 23, 2010 | Not classified | Z-0592-2011 | Error in labeling | This product is being recalled due the product is miss-labeled as being sterilized by EO processing; however, the product was processed using Gamma sterilization. |
| Jun 7, 2005 | Not classified | Z-1571-05 | Other | Customer observed unsealed packages. |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intended use of this device is to protect equipment from contamination during a variety of procedures throughout the clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050322: Microtek Equipment Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050322
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026