510(k) Report

510(k) · Cleared

Cleared

Integuseal Microbial Sealant, Model IS 100 and 1S200

K052870510(k) TraditionalCleared Sep 29, 2006353-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

Kimberly-Clark Corp. · NZP Sealant, Microbial

Cleared on Sep 29, 2006 as substantially equivalent to K000442 (Medical Concepts Development, Inc., 2001) after a 353-day review. Its family tree reaches back 1 generation to 2001.

Decided
Sep 29, 2006
Review
353 days
Class
Class II
Product code
NZP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000442 (2001). No later device cites it as a predicate yet.

K000442 · Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648, D6650,D6651, D66XX · Medical Concepts Development, Inc. · 200120002002200420062008
K000442 · Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648, D6650,D6651, D66XX · Medical Concepts Development, Inc. · 20010
  1. Root · 1 generation backK000442 Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648…Medical Concepts Development, Inc. · 2001
  2. This deviceK052870 Integuseal Microbial Sealant, Model IS 100 and 1S200Kimberly-Clark Corp. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000442Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648, D6650,D6651, D66XXMedical Concepts Development, Inc.2001—
0 (this device)K052870Integuseal Microbial Sealant, Model IS 100 and 1S200Kimberly-Clark Corp.2006—
FIG. 1 — Lineage of K052870, 2001–2006Source: 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 NZP? 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 NZP device

  1. #1 K223669 SecurePortIV Advanced Catheter Securement…score 5.8 · 2 generations · no Class I recall
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
*K000442Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648, D6650,D6651, D66XX
Summary page 1
…me: 878.4370 Surgical Drape Accessory Predicate Device(s): Medical Development Concepts ACTI-Gard Antimicrobial Film (K000442) Device Description: INTEGUSEAL Microbial Sealant is a film-forming cyanoacrylate-based…
Medical Concepts Development, Inc.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?

  • Its one ancestor has no recall.

How does its category compare?

All NZP devices

NZP Sealant, Microbial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NZP

1in 2023

2009: 12017: 12023: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NZP

Too few NZP 510(k)s in any year since 2007 to give a median.

Recalls per year · NZP

No recall names NZP since 2007.

Adverse event reports per year · NZP

1in 2025

2011: 12015: 42016: 12021: 32023: 12025: 1
2007high 4 (2015) · low 0 (2007)2025

MAUDE reports naming product code NZP, 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
20070—00
20080—00
20091—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—04
20160—01
20171—00
20180—00
20190—00
20200—00
20210—03
20220—00
20231—01
20240—00
20250—01
20260—0—

What is it indicated for?

Integuseal Microbial Sealant is intended for use after typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure.

Indications for use as stated in the FDA summary.

More from Kimberly-Clark Corp.

104 FDA decisions under this applicant name. See the company

  • K140963Kimguard Smart-Fold Sterilization WrapKimberly-Clark Corp. · 2014
  • K141294U by Kotex Security Unscented Menstrual TamponsKimberly-Clark Corp. · 2014
  • K131879KC 300 Surgical MaskKimberly-Clark Corp. · 20131 recall
  • K131841Kimberly-Clark Lavender Nitrile Powder-Free Exam GloveKimberly-Clark Corp. · 2013
  • K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp. · 20135 Class I recalls

Recent decisions in NZP

The NZP category page

  • K223669SecurePortIV Advanced Catheter Securement AdhesiveAdhezion Biomedical, LLC · 2023
  • K170505SecurePortIV Catheter Securement AdhesiveAdhezion Biomedical, LLC · 2017
  • K083354Floraseal, Model FS350DAdhezion Biomedical · 2009

https://510kreport.com/device/K052870 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052870: Integuseal Microbial Sealant, Model IS 100 and 1S200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052870

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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