Skip to content

PIASMA SAFE

by Cry-O-Safe, Inc. 510(k)

Active United States

510(k) K792185

Overview

The PIASMA SAFE is a container, empty, for collection and processing of blood and blood components. It is a Class II medical device manufactured by Cry-O-Safe, Inc. and is designed for use in hematology applications.

The device is supplied as a single-use container and is not specified as MRI safe. It is authorized under FDA 510(k) clearance with number K792185, received on October 31, 1979, and cleared on December 28, 1979. The device is regulated under product code KSR and regulation number 864.9100.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792185 Date28 Dec 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KSR
Device Class
Class II
Regulation
21 CFR Part 864.9100
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the PIASMA SAFE container used for?

    The PIASMA SAFE is a container designed for the collection and processing of blood and blood components. It is specifically intended for use in hematology applications as a Class II medical device.

  • Is the PIASMA SAFE container reusable or single-use?

    The PIASMA SAFE is supplied as a single-use container and is not intended for reuse. This design ensures safety and prevents cross-contamination between different blood samples.

  • What is the regulatory status of the PIASMA SAFE container?

    The PIASMA SAFE is authorized under FDA 510(k) clearance with number K792185, received on October 31, 1979, and cleared on December 28, 1979. It is regulated under product code KSR and regulation number 864.9100.

  • Is the PIASMA SAFE container MRI safe?

    The PIASMA SAFE container is not specified as MRI safe. It is designed specifically for blood collection and processing in hematology applications, not for use in MRI environments.