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Mityvac

by Prism Enterprises, Inc.

510(k) K011532

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK011532 Date30 Jul 2001ClearedStatusActive

Recalls

4 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1888-2008 FDA Unclassified (pre-2012) initiated 16 Jan 2008
    • Terminated Z-1887-2008 FDA Unclassified (pre-2012) initiated 16 Jan 2008
    • Terminated Z-1889-2008 FDA Unclassified (pre-2012) initiated 16 Jan 2008

    Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby.

    • Terminated Z-0005-05 FDA Unclassified (pre-2012) initiated 17 Aug 2004

    Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System

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  • Withdrawn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
HDB
Device Class
Class II
Regulation
21 CFR Part 884.4340
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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