510(k) · Cleared
Recalled · Class II · 2021Emm Equipment Cover-Polythylene
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exact Medical Manufacturing, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Sep 20, 2010 as substantially equivalent to K083234 (Kimberly-Clark Corp., 2009) after a 96-day review. Its family tree reaches back 2 generations to 2008. It has been recalled once.
- Decided
- Sep 20, 2010
- Review
- 96 days
- Class
- Class II
- Product code
- KKX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K080629 (2008). No later device cites it as a predicate yet.
- Root · 2 generations backK080629 Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover…Promedical Products Co., Ltd. · 2008
- 1 generation backK083234 Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark…Kimberly-Clark Corp. · 2009 · Recalled
- This deviceK101689 Emm Equipment Cover-PolythyleneExact Medical Manufacturing, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K080629 | Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band Bags | Promedical Products Co., Ltd. | 2008 | — |
| −1 | K083234 | Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100… | Kimberly-Clark Corp. | 2009 | 2 |
| 0 (this device) | K101689 | Emm Equipment Cover-Polythylene | Exact Medical Manufacturing, Inc. | 2010 | — |
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? (1)
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 |
|---|---|---|---|
| * | K083234 | Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical…Summary page 1…substantially equivalent and meets the same acceptance criteria as the predicate device/gown in K083234. Non-clinical performance testing includes: barrier properties- Le… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2021 | Class II | Z-1907-2021 | No Marketing Application | No 510k for the product to be used in a natural or surgical opening to the body |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K083234.
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?
Exact Medical Manufacturing Equipment Cover - Polyethylene are sterile single use devices made of natural or synthetic materials intended to be used as a protective equipment covering, such as to isolate equipment from microbial and other contamination.
The Exact Medical Manufacturing Equipment Covers-Polyethylene are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101689: Emm Equipment Cover-Polythylene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101689
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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