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Kimberly-Clark KC100 Surgical Drapes, Model Kc 100, Kimberly-Clark KC100 Surgical Equipment Covers, Model Kc 100

by Kimberly-Clark Corp.

510(k) K083234

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083234 Date25 Mar 2009ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2520-2025 FDA Class II initiated 17 Jul 2025

    Surgical drape packs may have open seals, which may compromise the sterility of the product.

    • Ongoing Z-0983-2025 FDA Class II initiated 26 Nov 2024

    Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KKX
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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