Cleared Traditional

K131053 - ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131053 · The Anspach Effort, Inc. · Ear, Nose, Throat device
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Dec 2013
Decision
259d
Days
Class 2
Risk

K131053 is an FDA 510(k) clearance for the ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Tampa, US). The FDA issued a Cleared decision on December 31, 2013 after a review of 259 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - the FDA ear, nose and throat 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all The Anspach Effort, Inc. devices

Submission Details

510(k) Number K131053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2013
Decision Date December 31, 2013
Days to Decision 259 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 89d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 90
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K131053.
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