Cleared Traditional

K844131 - NUCLEOTOME

K844131 is an FDA 510(k) clearance for NUCLEOTOME, manufactured by Medical Instrument Development Laboratories, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K844131 · Medical Instrument Development Laboratories, Inc. · Orthopedic device
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Nov 1984
Decision
37d
Days
Class 1
Risk

K844131 is an FDA 510(k) clearance for the NUCLEOTOME. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on November 29, 1984 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory 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 Medical Instrument Development Laboratories, Inc. devices

FDA 510(k) Submission Details - K844131

510(k) Number K844131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date November 29, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 122d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 33
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K844131.
REPLACEMENT HOSES
K861405 · Micro-Aire Surgical Instruments, Inc. · Apr 1986
MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER
K851443 · Micro-Aire Surgical Instruments, Inc. · May 1985
ACUFEX ARTHROSCOPIC SHAVER
K844130 · Acufex Microsurgical, Inc. · Mar 1985
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT
K840831 · Cabot Medical Corp. · Apr 1984
ANSPACH 65,000
K831756 · The Anspach Effort, Inc. · Sep 1983
MICRO OSCILLATING SAW
K811834 · Micro-Aire Surgical Instruments, Inc. · Jul 1981