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Specimen Adaptor

by Bemis Health Care

510(k) K822557

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK822557 Date18 Oct 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
BYZ
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Specimen Adaptor 533510 is a sterile, single-use medical device classified as a trap for specimen collection. Designed as an accessory, it facilitates the transfer of biological samples from suction canisters to collection containers, ensuring compatibility with sterile procedures in clinical settings. Its primary function is to maintain specimen integrity while minimizing contamination risks during transfer.

This device is supplied in a case of 10 units and is intended for single-use applications in general hospital environments. It adheres to FDA 510(k) clearance under the traditional pathway, with a decision code of SESE, indicating substantial equivalence to prior devices. The adaptor is non-magnetic and not intended for MRI use, requiring proper storage in a clean, dry environment to preserve sterility and functionality.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Specimen Adaptor 533510 used for?

    The Specimen Adaptor 533510 is a sterile, single-use medical device designed as a trap to facilitate the transfer of biological samples between suction canisters and collection containers. Its primary purpose is to maintain specimen integrity while minimizing contamination risks during the transfer process, ensuring compatibility with sterile clinical procedures.

  • How is the Specimen Adaptor 533510 supplied, and is it reusable?

    The Specimen Adaptor 533510 is supplied in a case containing 10 individual, sterile units. It is explicitly intended for single-use applications only, meaning each adaptor should be discarded after one use to prevent cross-contamination and ensure sterility.

  • What storage conditions are required to preserve the adaptor’s sterility and functionality?

    To maintain sterility and functionality, the Specimen Adaptor 533510 must be stored in a clean, dry environment. Avoid exposure to moisture, extreme temperatures, or contamination. Proper storage ensures the adaptor remains effective for its intended single-use application.

  • Can the Specimen Adaptor 533510 be used with MRI equipment?

    No, the Specimen Adaptor 533510 is explicitly designed as a non-magnetic device and is not intended for use in MRI environments. Always verify compatibility with imaging equipment before use.

  • What regulatory pathway does the Specimen Adaptor 533510 follow?

    The Specimen Adaptor 533510 has received FDA 510(k) clearance under the traditional pathway, with a decision code of SESE (Substantially Equivalent). This classification indicates it meets regulatory standards by demonstrating equivalence to previously cleared devices in the same category.