510(k) Report

510(k) · Cleared

Cleared

Modification to: Compel Surgical Drapes

K012807510(k) SpecialCleared Oct 11, 200150-day reviewClass II21 CFR 878.4370

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Standard Textile Co., Inc. · KKX Drape, Surgical, Antimicrobial

Cleared on Oct 11, 2001 as substantially equivalent to K923811 (Standard Textile Co., Inc., 1993) after a 50-day review. Its family tree reaches back 1 generation to 1993.

Decided
Oct 11, 2001
Review
50 days
Class
Class II
Product code
KKX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K923811 (1993). No later device cites it as a predicate yet.

K923811 · Compel Surgical Drapes · Standard Textile Co., Inc. · 19931990199219941996199820002002
K923811 · Compel Surgical Drapes · Standard Textile Co., Inc. · 19930
  1. Root · 1 generation backK923811 Compel Surgical DrapesStandard Textile Co., Inc. · 1993
  2. This deviceK012807 Modification to: Compel Surgical DrapesStandard Textile Co., Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K923811Compel Surgical DrapesStandard Textile Co., Inc.1993—
0 (this device)K012807Modification to: Compel Surgical DrapesStandard Textile Co., Inc.2001—
FIG. 1 — Lineage of K012807, 1993–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K923811Compel Surgical Drapes
Summary page 1
…Covers Classification Name: Fenestrated Surgical Drapes/Covers Non-fenestrated Surgical Drapes/Covers Regulation #878.4370 3. Predicate Device: ComPel Surgical Drapes #K923811 4. All base fabrics used in the construction of ComPel Surgical Drapes are made from 100% polyester, knitted or woven into fabr…
Standard Textile Co., Inc.1993—

Also cleared against K923811: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K923811.

How does its category compare?

All KKX devices

KKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KKX

2in 2023

2007: 42008: 52009: 52010: 82011: 42012: 22013: 32014: 62015: 22017: 12020: 12021: 12023: 2
2007high 8 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KKX

182in 2014

2007: 181 days median2008: 164 days median2009: 114 days median2010: 107 days median2011: 147 days median2013: 227 days median2014: 182 days median
2007high 227 (2013) · low 107 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KKX

2in 2024

2007: 12010: 12011: 12012: 12013: 72014: 7, 7 Class I2016: 42024: 22026 (partial year): 2
2007high 7 (2013) · low 0 (2008)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · KKX

24in 2025

2007: 242008: 242009: 272010: 252011: 572012: 402013: 632014: 282015: 332016: 562017: 302018: 322019: 412020: 162021: 412022: 192023: 322024: 192025: 24
2007high 63 (2013) · low 16 (2020)2025

MAUDE reports naming product code KKX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074181124
20085164024
20095114027
20108107125
20114147157
20122—140
20133227763
201461827 (7)28
20152—033
20160—456
20171—030
20180—032
20190—041
20201—016
20211—041
20220—019
20232—032
20240—219
20250—024
20260—2—

What is it indicated for?

ComPel Surgical Drapes are intended to cover patients or working surfaces during surgical procedures.

ComPel Surgical Drapes and Covers are made of synthetic materials intended to be used as protective patient coverings, such as to isolate a site of surgical incision from microbial and other contamination.

ComPel Surgical Drapes will function as a surgical drape when processed according to instructions. The ComPel Surgical Drapes are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K923811

1 other device cites the same predicate.

  • K980183Promax Surgical Drapes and CoversStandard Textile Co., Inc. · 1998

More from Standard Textile Co., Inc.

23 FDA decisions under this applicant name. See the company

  • K241214ProPel SG3™ Surgical GownStandard Textile Co., Inc. · 2024
  • K172207Standard Supreme Sterilization WrapperStandard Textile Co., Inc. · 2017
  • K162162Barrier Supreme Sterilization WrapperStandard Textile Co., Inc. · 2016
  • K060181COMPE1 1 -Ply Surgical GownsStandard Textile Co., Inc. · 2006
  • K041653Compel 1-Ply Surgical Gowns; Compel Isolation GownsStandard Textile Co., Inc. · 2005

Recent decisions in KKX

The KKX category page

  • K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical, Ltd. · 2023
  • K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company · 2023
  • K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba · 2021
  • K200238ControlRad Sterile CoverControlrad, Inc. · 2020
  • K163556MediClear PreOpCovalontechnologies, Inc. · 2017

https://510kreport.com/device/K012807 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012807: Modification to: Compel Surgical Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012807

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026