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Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line

by Oridion Medical 1987 Ltd.

510(k) K013845

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 · Special NumberK013845 Date29 Nov 2001ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1334-2012 FDA Not yet classified initiated 16 Feb 2012
    • Terminated Z-1333-2012 FDA Not yet classified initiated 16 Feb 2012

    CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.

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  • Withdrawn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
CCK
FDA applicant
Oridion Medical 1987 , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.1400
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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