Cleared Traditional

K900826 - 'APNEA-ELECTRODE'

K900826 is an FDA 510(k) clearance for 'APNEA-ELECTRODE', manufactured by Medical Science Products, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K900826 · Medical Science Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
64d
Days
Class 2
Risk

K900826 is an FDA 510(k) clearance for the 'APNEA-ELECTRODE'. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Medical Science Products, Inc. (Canal Fulton, US). The FDA issued a Cleared decision on April 26, 1990 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory 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 Medical Science Products, Inc. devices

FDA 510(k) Submission Details - K900826

510(k) Number K900826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1990
Decision Date April 26, 1990
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 140d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 108
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K900826.
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
K884120 · S & W Medico Teknik · Jul 1990
MODEL 9200 RESPIRATION/HEART RATE MONITOR
K901656 · Aequitron Medical, Inc. · Jul 1990
MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
K902785 · Aequitron Medical, Inc. · Jul 1990
AR-800PA RESPIRATION MODULE
K891486 · Nihon Kohden America, Inc. · Oct 1989
MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
K884637 · Aequitron Medical, Inc. · Jan 1989
MODEL 9216 RESPIRATION/HEART RATE MONITOR
K881266 · Aequitron Medical, Inc. · Jun 1988