Cleared Traditional

K011327 - DB1 EMBRYO FREEZE

K011327 is an FDA 510(k) clearance for DB1 EMBRYO FREEZE, manufactured by Zander Medical Supplies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 471-day FDA review.

K011327 · Zander Medical Supplies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
471d
Days
Class 2
Risk

K011327 is an FDA 510(k) clearance for the DB1 EMBRYO FREEZE. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Zander Medical Supplies, Inc. (Vero Beach, US). The FDA issued a Cleared decision on August 15, 2002 after a review of 471 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K011327

510(k) Number K011327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2001
Decision Date August 15, 2002
Days to Decision 471 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
310d slower than avg
Panel avg: 161d · This submission: 471d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQG Device Classification - Class 2, Special Controls

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQG Accessory, Assisted Reproduction

All 46
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K011327.
BINDER CO2 INCUBATOR SERIE CB
K032526 · Binder GmbH · Aug 2003
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
K030525 · Mid-Atlantic Diagnostics, Inc. · Aug 2003
KENDRO HERACELL 240 INCUBATOR
K023465 · Kendro Laboratory Products, L.P. · Mar 2003
WORKBENCH BY
K020560 · Intl., Inc. · Jun 2002
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS
K021042 · Thermo Forma, Inc. · May 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc. · Feb 2002
K011327 · DB1 EMBRYO FREEZE
Download PDF FDA Summary Zander Medical Suppli…