Cleared Traditional

K172986 - Zmachine Synergy (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172986 · Consolidated Research of Richmond, Inc. Dba General Sleep CO · Neurology device
Download Printable Device Report (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.

View all Consolidated Research of Richmond, Inc. Dba General Sleep CO devices

Submission Details

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
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 148d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.
Noxturnal Web
K260585 · Nox Medical Ehf · Mar 2026
Falcon HST
K242447 · Compumedics Limited · Feb 2025
Noxturnal Web
K241288 · Nox Medical Ehf · Dec 2024
HomeSleepTest (HST, HST REM+)
K240700 · Somnomedics GmbH · Dec 2024
Cerebra Sleep System
K213007 · Cerebra Medical , Ltd. · Jul 2022
SOMNOscreen plus
K201054 · Somnomedics GmbH · Aug 2020