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Nasopore Ear

by Polyganics B.V.,

510(k) K070715

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

13 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070715 Date7 May 2007ClearedStatusActive

Recalls

13 recalls · 13 ongoing · FDA

  • 13 recalls, same reason

    • Ongoing Z-1473-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1476-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1470-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1481-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1479-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1477-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1472-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1482-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1480-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1475-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1471-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1469-2025 FDA Class II initiated 25 Feb 2025
    • Ongoing Z-1478-2025 FDA Class II initiated 25 Feb 2025

    There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

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  • Withdrawn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
NHB
Device Class
Class II
Regulation
21 CFR Part 874.3620
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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