Skip to content

DB1 Embryo Freeze

by Zander Medical Supplies, Inc.

510(k) K011327

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 NumberK011327 Date15 Aug 2002ClearedStatusActive

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  • Withdrawn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
MQG
Device Class
Class II
Regulation
21 CFR Part 884.6120
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 DB1 Embryo Freeze is an Accessory, Assisted Reproduction device designed for cryopreservation of gametes and embryos. It is classified as a Class II medical device under FDA regulation 884.6120 and serves as instrumentation for freezing, containing, and maintaining biological specimens at controlled sub-zero temperatures. This device is intended for use in assisted reproductive technologies to preserve fertility by storing embryos or sperm in a stable, viable state for future use.

The DB1 Embryo Freeze is supplied as a reusable device and is intended for use in clinical settings such as fertility clinics or assisted reproduction laboratories. It operates at cryogenic temperatures to facilitate long-term storage of biological samples, adhering to sterility protocols for medical use. The device was granted FDA 510(k) clearance under the Traditional review pathway, with a clearance date of August 15, 2002, and is categorized under the MQG product code. No third-party certification is indicated in the regulatory records.

Other devices from Zander Medical Supplies, Inc.