Cleared Traditional

K013091 - ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM

K013091 is an FDA 510(k) clearance for ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL..., manufactured by Von Zeppelin GmbH. The device is a Class 2 Neurology device with product code HBB cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K013091 · Von Zeppelin GmbH · Neurology device
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Jan 2002
Decision
130d
Days
Class 2
Risk

K013091 is an FDA 510(k) clearance for the ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Von Zeppelin GmbH (Pullach, DE). The FDA issued a Cleared decision on January 25, 2002 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - 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 Von Zeppelin GmbH devices

FDA 510(k) Submission Details - K013091

510(k) Number K013091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2001
Decision Date January 25, 2002
Days to Decision 130 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 148d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBB Device Classification - Class 2, Special Controls

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
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.

Regulatory Peers - HBB Motor, Drill, Pneumatic

All 22
Devices cleared under the same product code (HBB) and FDA review panel - the closest regulatory comparables to K013091.
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