Cleared Traditional

K121507 - ATRICURE CRYO MODULE SYSTEM (ACM

K121507 is the FDA 510(k) clearance for ATRICURE CRYO MODULE SYSTEM (ACM by AtriCure, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEH) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K121507 · AtriCure, Inc. · General & Plastic Surgery device
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Jun 2012
Decision
16d
Days
Class 2
Risk

K121507 is an FDA 510(k) clearance for the ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE). Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on June 6, 2012 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K121507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2012
Decision Date June 06, 2012
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 73
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K121507.
cryoFORM cryoICE cryoablation probe
K152337 · AtriCure, Inc. · Mar 2016
cryoICE croablation probe
K142441 · AtriCure, Inc. · Oct 2014
ATRICURE CRYO MODULE SYSTEM
K140058 · AtriCure, Inc. · Jan 2014
ATRICURE CRYO MODULE SYSTEM
K112072 · AtriCure, Inc. · Aug 2011
ATRICURE CRYO MODULE
K111042 · AtriCure, Inc. · May 2011
ATRICURE CRYO1 CRYO-ABLATION PROBE
K082074 · AtriCure, Inc. · Mar 2009

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.