Skip to content

Falcon IVF Round Dish

by Becton Dickinson Labware

510(k) K991253

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 NumberK991253 Date5 May 1999ClearedStatusActive

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  • Withdrawn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
MQK
Device Class
Class II
Regulation
21 CFR Part 884.6160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Falcon IVF Round Dish is a sterile, single-use labware device designed for assisted reproduction procedures. Classified under Labware, Assisted Reproduction (product code MQK), it is intended for the manipulation and observation of ova and embryos during in vitro fertilization (IVF) processes. Its optically clear, flat surface facilitates precise handling and monitoring under laboratory conditions.

Supplied as a sterile, single-use item, the Falcon IVF Round Dish is intended for use in clinical settings such as fertility clinics and IVF laboratories. It is manufactured under regulatory oversight, including FDA 510(k) clearance (K991253) under the classification of Class II – Special Controls, with regulatory number 884.6160. The dish is designed to maintain stable temperatures during procedures, ensuring optimal conditions for embryo culture and observation.

Other devices from Becton Dickinson Labware

Questions

AI-generated answers, 19 Sep 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 Falcon IVF Round Dish primarily used for in clinical settings?

    The Falcon IVF Round Dish is specifically designed for assisted reproduction procedures, particularly for the manipulation and observation of ova and embryos during in vitro fertilization (IVF). Its optically clear, flat surface allows for precise handling and monitoring under laboratory conditions, ensuring optimal conditions for embryo culture.

  • Is the Falcon IVF Round Dish intended for single-use or repeated use?

    The Falcon IVF Round Dish is explicitly labeled as a sterile, single-use item. This design ensures patient safety and prevents cross-contamination between procedures, which is critical in fertility clinics and IVF laboratories.

  • How is the Falcon IVF Round Dish regulated, and what does that mean for buyers?

    The Falcon IVF Round Dish holds FDA 510(k) clearance (K991253) under the classification of Class II – Special Controls, with regulatory number 884.6160. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring compliance with safety and performance standards for labware used in assisted reproduction procedures.

  • What types of environments or facilities should use the Falcon IVF Round Dish?

    The dish is intended for use in clinical settings such as fertility clinics and IVF laboratories, where controlled environments are essential. Its design supports stable temperature maintenance during procedures, which is critical for embryo culture and observation in assisted reproduction workflows.