Product Code: FLS FDA class 2 21 CFR 868.2377

Monitor, Apnea, Facility Use

Anesthesiology

The Facility-Use Apnea Monitor is a device used in clinical settings to detect the cessation of breathing (apnea) in patients and generate an alarm to alert healthcare staff. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FLS, regulated under 21 CFR 868.2377 in the Anesthesiology specialty. This device is designated as life sustaining or life supporting.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code FLS in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: FLS
Device Class: FDA class 2
Regulation Number: 868.2377
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K011597	SMARTMONITOR 2, MODEL 4000	Jan 11, 2002	Substantially Equivalent	Respironics Georgia, Inc.
K991087	HANNAH WIRELESS VITAL SIGNS MONITOR	Jan 12, 2000	Substantially Equivalent - Subject to Tracking Reg.	Ilife Systems, Inc.
K962865	REMBRANDT SYSTEM	Oct 25, 1996	Substantially Equivalent - Subject to Tracking Reg.	Airsep Corp.
K951246	PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS	Feb 02, 1996	Substantially Equivalent - Subject to Tracking Reg.	Protocol Systems, Inc.
K894973	RESPITRACE PLUS	Oct 30, 1989	Substantially Equivalent	Hogan & Hartson
K832999	RESPIRATION MONITOR	Feb 13, 1984	Substantially Equivalent	Litton Medical Electronics
K830778	MONITORING KIT AMK-1	Oct 14, 1983	Substantially Equivalent	Alternative Design Systems, Inc.
K822077	RESPIRATION MONITOR TYPE MR-10	Oct 06, 1982	Substantially Equivalent	New Dimensions IN Medicine, Inc.
K821721	CLINICAL DATA APNEA DETECTOR	Jul 13, 1982	Substantially Equivalent	Clinical Data, Inc.
K820943	SYSTEM I INFANT MONITORING SYS	May 03, 1982	Substantially Equivalent	Burr Engineering & Development Co.
K810153	VENTILATORY EFFORT MONITOR	Feb 09, 1981	Substantially Equivalent	Medicon, Inc.
K802710	INFANT APNEA MONITOR	Nov 12, 1980	Substantially Equivalent	Douglas Scientific Products
K800164	413A NEONATAL MONITOR	Apr 10, 1980	Substantially Equivalent	Xerox Corp.
K781216	INFUSION CONTROLLER, PARENTERAL	Aug 10, 1978	Substantially Equivalent	National Patent Development Corp.
K760635	MEDI-DYNE APNEA MONITOR	Sep 21, 1976	Substantially Equivalent	Med Dyne Inst., Inc.
K760104	RESPIRATION MONITOR	Sep 21, 1976	Substantially Equivalent	Air-Shields, Inc.