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Sensor Medics 4000 Series Sleep System

by Sensor Medics Corp.

510(k) K915856

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915856 Date26 Oct 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Sensormedics 4000 Series Sleep System
510(k) Number
FDA Product Code
OLZ
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sensor Medics 4000 Series Sleep System is an automatic event detection software for polysomnograph with electroencephalograph. It is classified as a Class II medical device under regulation number 882.1400 and product code OLZ, with a neurology medical specialty designation.

The device received FDA 510(k) clearance K915856 on October 26, 1992, following a traditional review process. It was found substantially equivalent to a predicate device and is manufactured by Sensor Medics Corp. in Yorba Linda, California.

Other devices from Sensor Medics Corp.

See all devices from Sensor Medics Corp. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Sensor Medics 4000 Series Sleep System used for?

    The Sensor Medics 4000 Series Sleep System is automatic event detection software designed for use with polysomnograph and electroencephalograph equipment to identify sleep-related events during diagnostic testing.

  • How is the Sensor Medics 4000 Series Sleep System supplied or deployed?

    The device is software intended for installation and use with compatible polysomnograph and electroencephalograph systems; it is not a physical implant or disposable item but runs on clinical computing hardware.

  • Is the Sensor Medics 4000 Series Sleep System sterile or single-use?

    As software, the Sensor Medics 4000 Series Sleep System does not require sterilization and is not subject to single-use limitations; it is reusable software that operates on standard medical computing platforms.

  • What regulatory pathway was used for the Sensor Medics 4000 Series Sleep System?

    The device obtained market authorization through the FDA 510(k) process under submission K915856, demonstrating substantial equivalence to a predicate device via a traditional review.