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Nutrifill

by Contamac, Ltd.

510(k) K181566

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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 NumberK181566 Date22 Oct 2018ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1956-2025 FDA Class II initiated 15 May 2025

    Contact lens insertion solution may lack sterility.

    • Terminated Z-0030-2022 FDA Class II initiated 27 Jul 2021

    Contact lens solution may contain foreign material

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  • Withdrawn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
MRC
Device Class
Class II
Regulation
21 CFR Part 886.5918
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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