510(k) Report

510(k) · Cleared

Cleared

Arrow International, Inc., Surgical Drapes

K071491510(k) TraditionalCleared Oct 10, 2007133-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

Arrow Intl., Inc. · KKX Drape, Surgical, Antimicrobial

Cleared on Oct 10, 2007 as substantially equivalent to K032666 (Medline Industries, Inc., 2005) and 1 other predicate after a 133-day review. Its family tree reaches back 1 generation to 1986.

Decided
Oct 10, 2007
Review
133 days
Class
Class II
Product code
KKX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K850960 (1986). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestorK850960 · Non-Absorbent Drapes & Absorbent Towels · Excel Health Care Products · 198619851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K850960 · Non-Absorbent Drapes & Absorbent Towels · Excel Health Care Products · 19860
  1. Root · 1 generation backK850960 Non-Absorbent Drapes & Absorbent TowelsExcel Health Care Products · 1986
  2. This deviceK071491 Arrow International, Inc., Surgical DrapesArrow Intl., Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K850960Non-Absorbent Drapes & Absorbent TowelsExcel Health Care Products1986—
0 (this device)K071491Arrow International, Inc., Surgical DrapesArrow Intl., Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K071491, 1986–2007Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K032666Medline Sterile Disposable Surgical Gowns/Drapes
Summary page 1
…common name: Drape Device classification name: Surgical drape and drape accessories.. Legally marketed devices to Medline Industries, Inc. Surgical Drape (K032666) and which the device is Pacon Manufacturing Corp. Surgical Drape (K850960) substantially equivalent: Description of th…
Medline Industries, Inc.2005—
*K850960Non-Absorbent Drapes & Absorbent Towels
Summary page 1
…accessories.. Legally marketed devices to Medline Industries, Inc. Surgical Drape (K032666) and which the device is Pacon Manufacturing Corp. Surgical Drape (K850960) substantially equivalent: Description of the device: Arrow Surgical Drapes are sterile, disposable patient…
Excel Health Care Products1986—

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.

How does its category compare?

All KKX devices

KKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

Arrow Surgical Drapes are intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination

Indications for use as stated in the FDA summary.

More from Arrow Intl., Inc.

110 FDA decisions under this applicant name. See the company

  • K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002…Arrow Intl., Inc. · 2010
  • K093050Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Arrow Intl., Inc. · 2009
  • K071998Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc. · 20072 recalls
  • K071111Non-Absorbable Silk SutureArrow Intl., Inc. · 2007
  • K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 200628 Class I recalls

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/K071491 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071491: Arrow International, Inc., Surgical Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071491

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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