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Hemo-Nate L-P Kit

by Int'L Corp.

510(k) K821814

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 NumberK821814 Date9 Jul 1982ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0233-2016 FDA Class II initiated 16 Oct 2015

    Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where the seal between the Tyvek lid and the PETG tray on one side of the tray had been compromised.

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  • Withdrawn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
KDD
Device Class
Class I
Regulation
21 CFR Part 878.4800
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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