510(k) · Cleared
ClearedDrape, Surgical-Latex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Protek Medical Products, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Aug 22, 1997 as substantially equivalent to K895614 (CIVCO Medical Instruments Co., Inc., 1989) and 3 other predicates after a 164-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Aug 22, 1997
- Review
- 164 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K844472 (1985). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK844472 Civco Scan DrapeCIVCO Medical Instruments Co., Inc. · 1985
- This deviceK970891 Drape, Surgical-LatexProtek Medical Products, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844472 | Civco Scan Drape | CIVCO Medical Instruments Co., Inc. | 1985 | — |
| 0 (this device) | K970891 | Drape, Surgical-Latex | Protek Medical Products, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K895614 | Civco Latex Ultrasound SheathsSummary page 4…The following is a cross reference of products that will be identical: New Device Predicate Device PROTEK Medical Prod I Civeo’ Civeo’s S10(k! 1-519-0350 5 X 30 610-043 K895614 1-519-0380 8 X 30 610-044 K895614 1-519-0399 10 X 30 610-046 K895614 1-519-0320 2 X20 610-075 K895614 1-519-0326 2.6X20 610-213 K… | 1989 |
| * | K844472 | Civco Scan DrapeSummary page 4…. The same material manufactures and the same people that tested and processed Civco’s legally marketed devices. Other 510(k) numbers that have the same intended use are K844472 and K943393 under Civco Medical, K882724 MicroTek Probe Drape and 3m #1071 Drape PROTEK Medical Products Inc. Contact: Rick L. P… | 1985 |
| * | K943393 | Civco Probe Boot/Cord CoverSummary page 4…aterial manufactures and the same people that tested and processed Civco’s legally marketed devices. Other 510(k) numbers that have the same intended use are K844472 and K943393 under Civco Medical, K882724 MicroTek Probe Drape and 3m #1071 Drape PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone… | 1995 |
| * | K882724 | Microtek Probe DrapeSummary page 4…same people that tested and processed Civco’s legally marketed devices. Other 510(k) numbers that have the same intended use are K844472 and K943393 under Civco Medical, K882724 MicroTek Probe Drape and 3m #1071 Drape PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)359-82… | 1988 |
| * | — | Amedic of Sweden device Named without a submission number |
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.
What does this lineage say?
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K895614.
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?
Latex Drapes for Ultrasound Transducers.
A surgical drape and drape accessories used as a protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970891: Drape, Surgical-Latex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970891
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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