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Sediplast

by Precision Technology, Inc.

510(k) K840500

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840500 Date21 Feb 1984ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0107-2027 FDA Class II initiated 25 Aug 2026

    During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).

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  • Withdrawn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
JPH
Device Class
Class I
Regulation
21 CFR Part 864.6700
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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