Atlas FDA

FLS

16 FDA 510(k) clearances · Product code

84 daysmedian time to decision
287 days90th percentile
16clearances measured

FDA profile

Official device name
Monitor, Apnea, Facility Use
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2377
Medical specialty
Anesthesiology
Flags
Life-sustaining
Adverse events (MAUDE)
2010: 14 · 2011: 21 · 2012: 13 · 2013: 15 · 2014: 10 · 2015: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SMARTMONITOR 2, MODEL 4000 (K011597)Respironics Georgia, Inc.2002-01-11
HANNAH WIRELESS VITAL SIGNS MONITOR (K991087)Ilife Systems, Inc.2000-01-12
REMBRANDT SYSTEM (K962865)Airsep Corp.1996-10-25
PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS (K951246)Protocol Systems, Inc.1996-02-02
RESPITRACE PLUS (K894973)Hogan & Hartson1989-10-30
RESPIRATION MONITOR (K832999)Litton Medical Electronics1984-02-13
MONITORING KIT AMK-1 (K830778)Alternative Design Systems, Inc.1983-10-14
RESPIRATION MONITOR TYPE MR-10 (K822077)New Dimensions IN Medicine, Inc.1982-10-06
CLINICAL DATA APNEA DETECTOR (K821721)Clinical Data, Inc.1982-07-13
SYSTEM I INFANT MONITORING SYS (K820943)Burr Engineering & Development Co.1982-05-03
VENTILATORY EFFORT MONITOR (K810153)Medicon, Inc.1981-02-09
INFANT APNEA MONITOR (K802710)Douglas Scientific Products1980-11-12
413A NEONATAL MONITOR (K800164)Xerox Corp.1980-04-10
INFUSION CONTROLLER, PARENTERAL (K781216)National Patent Development Corp.1978-08-10
MEDI-DYNE APNEA MONITOR (K760635)Med Dyne Inst., Inc.1976-09-21
RESPIRATION MONITOR (K760104)Air-Shields, Inc.1976-09-21

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Every clearance here is in the API, with alerts when new ones post.