510(k) Report

510(k) · Cleared

Cleared

Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band Bags

K080629510(k) TraditionalCleared Oct 20, 2008229-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

Promedical Products Co., Ltd. · KKX Drape, Surgical, Antimicrobial

Cleared on Oct 20, 2008 after a 229-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Oct 20, 2008
Review
229 days
Class
Class II
Product code
KKX
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2011: 1 descendant cleared2010: 3 descendants cleared2013: 1 descendant cleared20052010201520202025
  1. This deviceK080629 Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover…Promedical Products Co., Ltd. · 2008
  2. Descendant · cites it directly · 5 of its ownK083234 Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark…Kimberly-Clark Corp. · 2009 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK102666 Kimberly-Clark Surgical Drapes with Aami Liquid Barrier Level 4 ClaimKimberly-Clark Corp. · 2010
  4. Descendant · 3 generations on · 0 of its ownK121919 Surgical Drape with Aami Liquid Barrier Level IVExact Medical Manufacturing, Inc. · 2013
  5. Descendant · 2 generations on · 0 of its ownK111458 Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment…Gri Medical & Electronic Technology Co., Ltd. · 2011
  6. Descendant · 2 generations on · 0 of its ownK101689 Emm Equipment Cover-PolythyleneExact Medical Manufacturing, Inc. · 2010 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12010: 32011: 12013: 1
2009high 3 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all
  • K083234Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical…Kimberly-Clark Corp. · 2009 · cites it directly5descendants
  • K102666Kimberly-Clark Surgical Drapes with Aami Liquid Barrier Level 4 ClaimKimberly-Clark Corp. · 2010 · 2 generations on1descendant
  • K121919Surgical Drape with Aami Liquid Barrier Level IVExact Medical Manufacturing, Inc. · 2013 · 3 generations on0descendants
  • K111458Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment CoversGri Medical & Electronic Technology Co., Ltd. · 2011 · 2 generations on0descendants
  • K101689Emm Equipment Cover-PolythyleneExact Medical Manufacturing, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K080629Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band BagsPromedical Products Co., Ltd.2008—
+1K083234Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100…Kimberly-Clark Corp.20092
+2K102666Kimberly-Clark Surgical Drapes with Aami Liquid Barrier Level 4 ClaimKimberly-Clark Corp.2010—
+3K121919Surgical Drape with Aami Liquid Barrier Level IVExact Medical Manufacturing, Inc.2013—
+2K111458Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment CoversGri Medical & Electronic Technology Co., Ltd.2011—
+2K101689Emm Equipment Cover-PolythyleneExact Medical Manufacturing, Inc.20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201030
201110
201310
FIG. 1 — Lineage of K080629, 2008–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083234Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical…Kimberly-Clark Corp.20095

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?

  • Of its descendants, K083234 (Kimberly-Clark Corp., 2009) has gone furthest, with 5 descendants of its own.

How does its category compare?

All KKX devices

KKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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?

proMedical Products Co. LTD intends to market sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

proMedical Products Co. LTD intends to market Sterile surgical equipment covers which are protective barrier covers that are intended to be used to cover sutqical equipment and provide a protective barrier for that equipment.

Indications for use as stated in the FDA 510(k) statement.

More from Promedical Products Co., Ltd.

6 FDA decisions under this applicant name. See the company

  • K091097Promedical Surgical Gown, Models 18-301, 18-401 and 18-501Promedical Products Co., Ltd. · 2009
  • K080627Promedical Surgical Gowns, Models: 1002494A, 100770APromedical Products Co., Ltd. · 2008
  • K042111Promedical Surgical GownsPromedical Products Co., Ltd. · 2004
  • K042131Promedical Surgical DrapesPromedical Products Co., Ltd. · 2004
  • K042137Promedical Surgical Mayo Stand Covers, Band Bags, Table Covers and Equipment CoversPromedical Products Co., Ltd. · 2004

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/K080629 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080629: Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band Bags.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080629

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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