Cleared Traditional

K960630 - ANSPAHC SPEED REDUCER

K960630 is an FDA 510(k) clearance for ANSPAHC SPEED REDUCER, manufactured by The Anspach Effort, Inc.. The device is a Class 2 Neurology device with product code HBB cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K960630 · The Anspach Effort, Inc. · Neurology device
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Nov 1996
Decision
284d
Days
Class 2
Risk

K960630 is an FDA 510(k) clearance for the ANSPAHC SPEED REDUCER. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on November 19, 1996 after a review of 284 days - an extended review cycle.

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 The Anspach Effort, Inc. devices

FDA 510(k) Submission Details - K960630

510(k) Number K960630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1996
Decision Date November 19, 1996
Days to Decision 284 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 148d · This submission: 284d
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 K960630.
AESCULAP HILAN MOTOR SYSTEM
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K954717 · Sodem Diffusion SA · Jan 1997
MIDAS REX III MOTOR
K962483 · Midas Rex Pneumatic Tools, Inc. · Nov 1996
MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
K953434 · Midas Rex Pneumatic Tools, Inc. · May 1996
MICROMEDICS SURGICAL DRILL SYSTEM
K895739 · Micromedics, Inc. · Oct 1989