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Origio Sequential Blast; Origio Sequential Blast with Phenol Red

FDA 510(k)

Class II (US FDA 510(k))

510(k) K133387

by Origio A/S

Identifiers

510(k) Number
K133387 FDA 510(k)
FDA Product Code
MQL FDA 510(k)
Models / Variants
Origio(r) Sequential Blast Tm FDA 510(k)
Origio(r) Sequential Blast Tm With Phenol Red FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.6180 FDA 510(k)
Regulation Number
884.6180 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a Reproductive Media designed for embryo culture in assisted reproductive technology (ART). It supports the development of embryos from the cleavage stage through to blastocyst formation, providing a nutrient-rich environment tailored to the metabolic needs of early-stage embryos.

Supplied as a sterile, single-use liquid medium, the device is intended for use in clinical embryology laboratories. It is available in two formulations—standard and with phenol red—and requires refrigeration prior to use. The product is classified as a Class II medical device under FDA regulations and has received 510(k) clearance for obstetrics/gynecology applications.

Frequently asked questions

What is the Origio Sequential Blast Media used for?

The Origio Sequential Blast Media is designed specifically for embryo culture in assisted reproductive technology (ART). It provides a nutrient-rich environment tailored to the metabolic needs of embryos as they develop from the cleavage stage through to blastocyst formation. This ensures optimal conditions for embryo growth and viability during in vitro fertilization (IVF) procedures.

How is the Origio Sequential Blast Media supplied and what are its key features?

The device is supplied as a sterile, single-use liquid medium in two formulations: a standard version and one with phenol red. It is intended exclusively for use in clinical embryology laboratories. The medium is pre-sterilized to prevent contamination and is packaged to maintain sterility until use. The phenol red formulation includes a pH indicator to help monitor the embryo culture environment visually.

Is the Origio Sequential Blast Media reusable or single-use?

The Origio Sequential Blast Media is strictly single-use only. This design ensures sterility and prevents cross-contamination between different embryo cultures, which is critical for maintaining the integrity and safety of reproductive procedures. Each unit is intended for one-time use in a single embryo culture session.

What storage conditions are required for the Origio Sequential Blast Media?

The device must be stored refrigerated prior to use. Proper refrigeration helps preserve the medium’s nutritional properties and sterility. Always follow the manufacturer’s instructions for storage temperature ranges to ensure the medium remains effective and safe for embryo culture. Avoid freezing, as this can compromise the medium’s performance.

Are there different models or sizes available for the Origio Sequential Blast Media?

The Origio Sequential Blast Media is available in two distinct formulations: one without phenol red and another with phenol red. Both formulations are designed to support embryo development but differ in their intended use for monitoring pH levels in the culture environment. No additional sizes are specified; the product is supplied in a standardized liquid form for embryo culture.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ORIGIO® Sequential Series™ - CooperSurgical, PDF ORIGIO Sequential BlastTM, Origio(R) Sequential Blast Tm; Origio(R) Sequential Blast Tm With ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Origio A/S

Sources (1)

  • FDA 510(k) K133387 24 fields · synced Oct 1, 2026