Skip to content

Slick Set

by Polamedco, Inc.

510(k) K780900

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

27 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 NumberK780900 Date17 Jul 1978ClearedStatusActive

Recalls

28 recalls · 27 ongoing · FDA

  • 26 recalls, same reason

    • Ongoing Z-1841-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1904-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1837-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1840-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1829-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1843-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1905-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1834-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1835-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1839-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1842-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1903-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1832-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1860-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1901-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1827-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1844-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1831-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1902-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1900-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1897-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1833-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1830-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1836-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1838-2023 FDA Class I initiated 25 May 2023
    • Ongoing Z-1828-2023 FDA Class I initiated 25 May 2023

    Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

    • Ongoing Z-1010-2023 FDA Class II initiated 8 Dec 2022

    Potential for pilot balloon non-inflation or cuff non-deflation.

    • Terminated Z-2319-2021 FDA Class II initiated 16 Jul 2021

    The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

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
BTR
Device Class
Class II
Regulation
21 CFR Part 868.5730
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Polamedco, Inc.

See all devices from Polamedco, Inc. →