510(k) · Cleared
ClearedImc Surgical Drape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medsurg Connection · KKX Drape, Surgical, Antimicrobial
Cleared on Oct 5, 2010 as substantially equivalent to K031287 (3M Company, 2003) and 1 other predicate after a 179-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Oct 5, 2010
- Review
- 179 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003755 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK003755 Medline Blockade or Resistat Surgical Gowns and Surggical DrapesMedline Industries, Inc. · 2001
- This deviceK100991 Imc Surgical DrapeInternational Medsurg Connection · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003755 | Medline Blockade or Resistat Surgical Gowns and Surggical Drapes | Medline Industries, Inc. | 2001 | — |
| 0 (this device) | K100991 | Imc Surgical Drape | International Medsurg Connection | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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 |
|---|---|---|---|
| * | K031287 | Steri-Drape Surgical DrapesSummary page 1…9-9927 1e-mail: peterkim intlmedsurg.com Date Prepared: June 7, 2010 Predicate Devices: *3M Steri-DrapeTM (K03 1287) Medline (K003755) Device Name(s): IMC Surgical Drape Classification Panel: General and P… | 2003 |
| * | K003755 | Medline Blockade or Resistat Surgical Gowns and Surggical DrapesSummary page 1…intlmedsurg.com Date Prepared: June 7, 2010 Predicate Devices: *3M Steri-DrapeTM (K03 1287) Medline (K003755) Device Name(s): IMC Surgical Drape Classification Panel: General and Plastic Surgery Legally Marketed Device Under Which S… | 2001 |
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?
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K031287.
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?
These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile. Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSIIAMMIIISO 1 13 5. Sterile drapes are to be sold directly to users after…
Read the full statement (111 words)
These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile.
Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSIIAMMIIISO 1 13 5. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSIIAMMIIISO 11135
Catalog Number Description
31 -0051 Bladder Suspension Drape
31 -0051 NS Bladder Suspension Drape
61-0091 GYN Procedure Drape
61-0091 NS G YN Procedure Drape
81-0011 TUR Procedure Drape
8i-0011iNS TUR Procedure Drape
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100991 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100991: Imc Surgical Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100991
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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