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Surestream 012686

by Oridion Medical 1987 Ltd.

Surestream 012686 is a Class II device made by Oridion Medical 1987 Ltd., cleared under FDA 510(k) K013845 on 29 Nov 2001 and listed in FDA GUDID since 9 Nov 2017 (UDI-DI 10884521552159), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K013845

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521552159 UDI-DI Date9 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK013845 Date29 Nov 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013845 decided 29 Nov 2001 Active
  • FDA GUDID UDI-DI 10884521552159 listed 9 Nov 2017 Listed

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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K013845
  2. Recall initiated FDA recalls Z-1334-2012
  3. Recall initiated FDA recalls Z-1333-2012
  4. Listed FDA GUDID 10884521552159

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Surestream
Generic name
Nasal oxygen cannula, carbon-dioxide-sampling
Model / reference
012686
Primary DI / UDI-DI
10884521552159
510(k) Number
FDA product code
CCK
GMDN term
Nasal oxygen cannula, carbon-dioxide-sampling
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Nasal oxygen cannula, carbon-dioxide-sampling

Cleared under the same submission (K013845)

Similar devices

Other devices filed under FDA product code CCK (ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE).

Other devices from Oridion Medical 1987 Ltd.

See all devices from Oridion Medical 1987 Ltd. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)