Cleared Traditional

K991900 - XLTEK POLYSOMNOGRAPHY HEADBOX

K991900 is the FDA 510(k) clearance for XLTEK POLYSOMNOGRAPHY HEADBOX by Excel Tech. , Ltd.. It is a Class 2 Neurology device (product code OLV) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K991900 · Excel Tech. , Ltd. · Neurology device
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Jul 1999
Decision
38d
Days
Class 2
Risk

K991900 is an FDA 510(k) clearance for the XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville,Ontario, CA). The FDA issued a Cleared decision on July 12, 1999 after a review of 38 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 Excel Tech. , Ltd. devices

Submission Details

510(k) Number K991900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1999
Decision Date July 12, 1999
Days to Decision 38 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 148d · This submission: 38d
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 26
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K991900.
BIO-LOGIC SLEEPSCAN NETLINK
K003681 · Bio-Logic Systems Corp. · Dec 2000
VITAPORT 3
K000338 · Nihon Kohden America, Inc. · Apr 2000
NEUROFAX, MODEL EEG-1100A
K992742 · Nihon Kohden America, Inc. · Oct 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
EMBLA
K971813 · Ferguson Medical · Jan 1998