Cleared Traditional

K012976 - TWIN PLUS

K012976 is an FDA 510(k) clearance for TWIN PLUS, manufactured by Grass-Telefactor Divison. The device is a Class 2 Neurology device with product code OLV cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K012976 · Grass-Telefactor Divison · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
160d
Days
Class 2
Risk

K012976 is an FDA 510(k) clearance for the TWIN PLUS. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Grass-Telefactor Divison (West-Warwick, US). The FDA issued a Cleared decision on February 12, 2002 after a review of 160 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K012976

510(k) Number K012976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2001
Decision Date February 12, 2002
Days to Decision 160 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
11d slower than avg
Panel avg: 149d · This submission: 160d
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 64
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K012976.
GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
K021807 · Grass Instrument Co. · Aug 2002
PSG INPUT BOX, MODEL JE-912AK
K022121 · Nihon Kohden America, Inc. · Jul 2002
NERVUS MONITOR
K021185 · Taugagreining HF · Jul 2002
NOTTA AMBULATORY RECORDER
K013450 · Stellate Systems · Jan 2002
SOMNO STAR & SERIES SLEEP SYSTEM
K012085 · Sensor Medics Corp. · Aug 2001
HARMONE-SCHWARZER EEG SYSTEM
K010728 · Stellate Systems · May 2001
K012976 · TWIN PLUS
Download PDF FDA Summary Grass-Telefactor Divi…