Cleared Traditional

K820943 - SYSTEM I INFANT MONITORING SYS

K820943 is an FDA 510(k) clearance for SYSTEM I INFANT MONITORING SYS, manufactured by Burr Engineering & Development Co.. The device is a Class 2 Anesthesiology device with product code FLS cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K820943 · Burr Engineering & Development Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1982
Decision
27d
Days
Class 2
Risk

K820943 is an FDA 510(k) clearance for the SYSTEM I INFANT MONITORING SYS. Classified as Monitor, Apnea, Facility Use (product code FLS), Class II - Special Controls.

Submitted by Burr Engineering & Development Co. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1982 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2377 - 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.

FDA 510(k) Submission Details - K820943

510(k) Number K820943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1982
Decision Date May 03, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 140d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLS Device Classification - Class 2, Special Controls

Product Code FLS Monitor, Apnea, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2377
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 - FLS Monitor, Apnea, Facility Use

All 9
Devices cleared under the same product code (FLS) and FDA review panel - the closest regulatory comparables to K820943.
RESPITRACE PLUS
K894973 · Hogan & Hartson · Oct 1989
RESPIRATION MONITOR
K832999 · Litton Medical Electronics · Feb 1984
CLINICAL DATA APNEA DETECTOR
K821721 · Clinical Data, Inc. · Jul 1982
INFUSION CONTROLLER, PARENTERAL
K781216 · National Patent Development Corp. · Aug 1978
RESPIRATION MONITOR
K760104 · Air-Shields, Inc. · Sep 1976
K820943 · SYSTEM I INFANT MONITORING SYS
Download PDF Burr Engineering & De…