510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Sterile Equipment Covers

K052395510(k) TraditionalCleared Dec 1, 200592-day reviewClass II21 CFR 878.4370Recalls 2

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

Volcano Corporation · KKX Drape, Surgical, Antimicrobial

Cleared on Dec 1, 2005 as substantially equivalent to K050322 (Microtek Medical, Inc., 2005) and 2 other predicates after a 92-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled 2 times.

Decided
Dec 1, 2005
Review
92 days
Class
Class II
Product code
KKX
Recalls
2
Predicates
3

Its longest line of descent runs back 2 generations to K931417 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 1 other ancestor2013: 1 descendant clearedK931417 · Sterile Equipment Covers · Custom Medical Products, Ltd. · 1995K961699 · Equipment Covers · United States Surgical, A Division of Tyco Healthc · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K961699 · Equipment Covers · United States Surgical, A Division of Tyco Healthc · 1996K931417 · Sterile Equipment Covers · Custom Medical Products, Ltd. · 19950
  1. Root · 2 generations backK931417 Sterile Equipment CoversCustom Medical Products, Ltd. · 1995
  2. 1 generation backK961699 Equipment CoversUnited States Surgical, A Division of Tyco Healthc · 1996
  3. This deviceK052395 Sterile Equipment CoversVolcano Corporation · 2005
  4. Descendant · cites it directly · 0 of its ownK121436 Das Medical Equipment DrapesDas Medical, LLC · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K121436Das Medical Equipment DrapesDas Medical, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K931417Sterile Equipment CoversCustom Medical Products, Ltd.1995—
−1K961699Equipment CoversUnited States Surgical, A Division of Tyco Healthc1996—
0 (this device)K052395Sterile Equipment CoversVolcano Corporation2005—
+1K121436Das Medical Equipment DrapesDas Medical, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K052395, 1995–2013Source: 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? (3)

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
*K050322Microtek Equipment Drapes
Summary page 1
…drape accessories ii Predicate Device: The Sterile Equipment Covers arc substantially equivalent to the MicroTek Equipment Drapes cleared under K050322 on May 17, 2005. Medline Band Bags and Equipment Covers cleared under K032065 on September 22. 2003, and United States Surgical C…
Microtek Medical, Inc.200517
*K032065Medline Band Bags and Equipment Covers
Summary page 1
…quipment Covers arc substantially equivalent to the MicroTek Equipment Drapes cleared under K050322 on May 17, 2005. Medline Band Bags and Equipment Covers cleared under K032065 on September 22. 2003, and United States Surgical Corporation cleared under K961699 on August 23, 1996. The Volcano Sterile Equip…
Medline Industries, Inc.20032
*K961699Equipment Covers
Summary page 1
…d under K050322 on May 17, 2005. Medline Band Bags and Equipment Covers cleared under K032065 on September 22. 2003, and United States Surgical Corporation cleared under K961699 on August 23, 1996. The Volcano Sterile Equipment Covers have the same Intended Uye and utilizes the same /indamenml scienlific l…
United States Surgical, A Division of Tyco Healthc1996—

Also cleared against K050322: 5 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K121436Das Medical Equipment DrapesDas Medical, LLC20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 5, 2016Class IIZ-1041-2016Labeling False and MisleadingVolcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
Feb 5, 2016Class IIZ-1042-2016Labeling False and MisleadingVolcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K121436 (Das Medical, LLC, 2013) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K050322.

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?

The Sterile Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field. These covers are not intended to be used as patient drapes and have no patient contact.

Indications for use as stated in the FDA summary.

Also cleared against K050322

5 other devices cite the same predicate.

  • K141438Whitney Medical Solutions EshieldWhitney Medical Solutions · 2014
  • K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013
  • K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
  • K081476Surgical Concept Designs Positionor Surgical DrapeSurgical Concept Designs · 2008
  • K052668OR Specific Big Case Back Table CoverOr Specific, Inc. · 2006

More from Volcano Corporation

55 FDA decisions under this applicant name. See the company

  • K210235Verrata PLUS Pressure Guide WireVolcano Corporation · 2021
  • K203719IntraSight MobileVolcano Corporation · 20211 recall
  • K202543OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipVolcano Corporation · 20201 recall
  • K192886OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipVolcano Corporation · 2020
  • K190626SyncVision SystemVolcano Corporation · 20191 recall

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/K052395 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052395: Sterile Equipment Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052395

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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