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Olympus High Flow Insufflation Unit

by Olympus America, Inc.

510(k) K953162

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK953162 Date19 Dec 1995ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1353-2026 FDA Class I initiated 16 Jan 2026
    • Ongoing Z-1352-2026 FDA Class I initiated 16 Jan 2026

    Issue with software algorithm which may lead to overpressure events.

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  • Withdrawn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
HIF
Device Class
Class II
Regulation
21 CFR Part 884.1730
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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