Cleared Traditional

K984580 - BIOSACA SYSTEM

K984580 is an FDA 510(k) clearance for BIOSACA SYSTEM, manufactured by Biosys AB (Publ). The device is a Class 2 Neurology device with product code OLV cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K984580 · Biosys AB (Publ) · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
79d
Days
Class 2
Risk

K984580 is an FDA 510(k) clearance for the BIOSACA SYSTEM. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Biosys AB (Publ) (Chester, US). The FDA issued a Cleared decision on March 12, 1999 after a review of 79 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 Biosys AB (Publ) devices

FDA 510(k) Submission Details - K984580

510(k) Number K984580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1998
Decision Date March 12, 1999
Days to Decision 79 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
69d faster than avg
Panel avg: 148d · This submission: 79d
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 43
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K984580.
BIOSACA SYSTEM, MODEL 800
K991446 · Biosys AB (Publ) · Jul 1999
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
K991900 · Excel Tech. , Ltd. · Jul 1999
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
K990522 · Lamont Medical, Inc. · May 1999
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
K983072 · Nihon Kohden America, Inc. · Dec 1998
MODIFICATION TO BIO-LOGIC SLEEPSCAN
K983913 · Bio-Logic Systems Corp. · Nov 1998
DEEGLITE
K974583 · Grass-Telefactor Product Group · Jun 1998