Cleared Traditional

K811628 - OECO APNEA MONITOR

K811628 is the FDA 510(k) clearance for OECO APNEA MONITOR by Oeco. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K811628 · Oeco · Anesthesiology device

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Jul 1981

Decision

52d

Days

Class 2

Risk

K811628 is an FDA 510(k) clearance for the OECO APNEA MONITOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Oeco (Walker, US). The FDA issued a Cleared decision on July 31, 1981 after a review of 52 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 Oeco devices

Submission Details

510(k) Number	K811628 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 09, 1981
Decision Date	July 31, 1981
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

88d faster than avg

Panel avg: 140d · This submission: 52d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 39

Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K811628.

COROMETRICS 500 INFANT MONITOR

K850504 · Ge Medical Systems Information Technologies · Jun 1985

EEG & RESPIRATION MODULES POLYGRAPH

K823563 · Nihon Kohden America, Inc. · Jan 1983

MEDDARS/ULTRA IMAGER RESPIRATION MODULE

K812667 · Honeywell, Inc. · Oct 1981

NEO NATAL RESPIRATION FUNCTION BLOCK

K810175 · Honeywell, Inc. · Mar 1981

RESPIRATION FUNCTION BLOCKS

K810174 · Honeywell, Inc. · Mar 1981

PDS MODEL 3000 ADULT RESPIRATION MODULE

K802046 · General Electric Co. · Sep 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K811628

Oeco

Walker, MI · US

Regulatory profile

2 submissions 2 cleared

100% clearance rate · Active in Anesthesiology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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