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Oxytote Infinity Series Vipr Systems

by Western/Scott Fetzer Co.

510(k) K142149

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK142149 Date17 Apr 2015ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0339-2020 FDA Class II initiated 15 Aug 2019
    • Terminated Z-0342-2020 FDA Class II initiated 15 Aug 2019
    • Terminated Z-0340-2020 FDA Class II initiated 15 Aug 2019
    • Terminated Z-0343-2020 FDA Class II initiated 15 Aug 2019
    • Terminated Z-0341-2020 FDA Class II initiated 15 Aug 2019

    Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

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  • Withdrawn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
ECX
Device Class
Class I
Regulation
21 CFR Part 868.2700
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent