Cleared Traditional

K964919 - EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM

K964919 is an FDA 510(k) clearance for EMERALD MEDICAL, manufactured by Emerald Medical, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K964919 · Emerald Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
50d
Days
Class 2
Risk

K964919 is an FDA 510(k) clearance for the EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Emerald Medical, Inc. (Brimfield, US). The FDA issued a Cleared decision on January 28, 1997 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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 Emerald Medical, Inc. devices

FDA 510(k) Submission Details - K964919

510(k) Number K964919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1996
Decision Date January 28, 1997
Days to Decision 50 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 487
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K964919.
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
K970055 · KARL STORZ Endoscopy-America, Inc. · Mar 1997
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM
K964879 · Davol Inc., Sub. C. R. Bard, Inc. · Mar 1997
COHORT DISCECTOMY SYSTEMS (CDS)
K964975 · Cohort Medical Products Group, Inc. · Feb 1997
STRYKER TEMPEST ORTHOPEDIC PUMP
K963304 · Stryker Endoscopy · Jan 1997
HSW GMBH ARTHROSCOPE
K962075 · Henke Sass Wolf of America, Inc. · Jan 1997
ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
K964215 · Smith & Nephew Endoscopy, Inc. · Dec 1996