Cleared Traditional

K172986 - Zmachine Synergy

K172986 is an FDA 510(k) clearance for Zmachine Synergy, manufactured by Consolidated Research of Richmond, Inc. Dba General Sleep CO. The device is a Class 2 Neurology device with product code OLV cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K172986 · Consolidated Research of Richmond, Inc. Dba General Sleep CO · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
83d
Days
Class 2
Risk

K172986 is an FDA 510(k) clearance for the Zmachine Synergy. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Consolidated Research of Richmond, Inc. Dba General Sleep CO (Cleveland, US). The FDA issued a Cleared decision on December 19, 2017 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K172986

510(k) Number K172986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date December 19, 2017
Days to Decision 83 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
66d faster than avg
Panel avg: 149d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLV Device Classification - Class 2, Special Controls

Product Code OLV Standard Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.
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 - OLV Standard Polysomnograph With Electroencephalograph

All 63
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K172986.
Serenity Piezo Sensor, Serenity Thermocouple Sensor
K181709 · Neurotronics, Inc. · Nov 2018
Serenity Body Position Sensor, Serenity RIP Sensors
K173868 · Neurotronics, Inc. · Jul 2018
Grass TWin
K173690 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Mar 2018
Comet-PLUS
K172711 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Nov 2017
Polysmith Sleep System, Model NTI7593
K161650 · Neurotronics, Inc. · Jan 2017
Polysmith Sleep System
K142774 · Neurotronics, Inc. · Feb 2015