510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K142825Substantially Equivalent

Zmachine

Consolidated Research of Richmond, Inc., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142825 is the FDA 510(k) clearance record for Zmachine, a class II device, cleared for Consolidated Research of Richmond, Inc. on under FDA product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph). FDA's definition for product code OLZ reads: "Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G...". FDA records list 2 510(k) clearances for Consolidated Research of Richmond, Inc., from to . As of , FDA records show no recalls naming K142825.

Clearance record

Decision date
Received
(112 days to decision)
Product code
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Consolidated Research of Richmond, Inc. 26250 Euclid Ave., Suite 709, Cleveland OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLZ

Trailing 12 months
4 clearances under product code OLZ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260