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Polestar N-10

by Odin Medical Technologies, Ltd.

510(k) K010850

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 · Traditional NumberK010850 Date17 Dec 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0352-2014 FDA Class I initiated 17 Oct 2013 on shared 510(k) K010850

    Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
LNH
FDA applicant
Odin Medical Technologies , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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