Cleared Traditional

K201752 - Disposable Pre-calibrated Suction

K201752 is the FDA 510(k) clearance for Disposable Pre-calibrated Suction by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K201752 · Brainlab AG · Neurology device
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Jan 2021
Decision
217d
Days
Class 2
Risk

K201752 is an FDA 510(k) clearance for the Disposable Pre-calibrated Suction. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on January 29, 2021 after a review of 217 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainlab AG devices

Submission Details

510(k) Number K201752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2020
Decision Date January 29, 2021
Days to Decision 217 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 148d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

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All 217
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