Atlas FDA

DSF

87 FDA 510(k) clearances · Product code

50 daysmedian time to decision
176 days90th percentile
87clearances measured

FDA profile

Official device name
Recorder, Paper Chart
Device class
Class I (low risk)
Regulation
21 CFR 870.2810
Medical specialty
Cardiovascular
Adverse events (MAUDE)
1992: 1 · 1994: 1 · 2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
EDENTEC DIGITAL CHARTER MODEL 3710 (K910871)Edentec Corp.1991-08-29
DASH IV (K912929)Astro-Med, Inc.1991-08-13
MODEL 556 MONITOR (K905856)Ge Medical Systems Information Technologies1991-01-11
GRI LASERGRAPH(TM) ECG PAPER (K902586)Gri Medical Products, Inc.1990-06-22
COLORADO COLOR IMAGING RECORDER (K902230)Honeywell, Inc.1990-06-19
GABRIEL MEDICAL CLS THERMAL RECORDER (K901385)Gabriel Medical, Inc.1990-05-09
TYPE 9541 RECORDER, PAPER CHART (K895111)S & W Medico Teknik1990-01-26
WR3500 AND WR3600 SERIES RECORDERS (K894922)Western Graphtec1990-01-26
MT96000 PAPER CHART RECORDER (K894736)Astro-Med, Inc.1989-12-13
PAQ10 PAPER CHART RECORDER (K894607)Protocol Systems, Inc.1989-10-26
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (K893561)Edentec Corp.1989-08-25
CARDIOCAP(TM) DR-104 REPORTER (K885058)Datex Division Instrumentarium Corp.1989-07-14
DUAL GRAPH (TM) RECORDER-MONITOR (K890711)Somatics, Inc.1989-06-02
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER (K884897)Mennen Medical, Inc.1989-03-09
A10 ULTRASCOPE RECORDER (K890142)Ems Medical, Inc.1989-02-06
CORTRONIC SCR1000 (K884911)Cortronic Corp.1989-01-13
EDENTEC MODEL 4700 SCANNER (K884388)Edentec Corp.1989-01-10
EDENTRACE MULTI-CHARTER MODEL 3700 (K883315)Edentec Corp.1988-12-28
WS 800R THERMAL ARRAY RECORDER (K881831)Nihon Kohden America, Inc.1988-07-14
LIFESTAT 1600 PRINTER (K881346)Physio-Control Corp.1988-06-09
DATALOGGER CHART RECORDER (K880781)Air-Shields, Inc.1988-05-11
VSM(R) R2 PAPER CHART RECORDER (K880554)Physio-Control Corp.1988-05-06
MODEL 78576A PAPER CHART RECORDER (K872822)Hewlett-Packard Co.1987-11-04
MODEL 192 PRINTER (K870538)Advanced Medical Products, Inc.1987-04-23
FIBRE OPTIC STRIP CHART RECORDER (K870119)Apex Imaging Corp.1987-04-10
IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM (K870039)Par Microsystems Corp.1987-02-12
SIREDOC 60 AND SIREDOC 220 (K863331)Siemens Medical Solutions USA, Inc.1986-10-06
DR-2C (MODIFICATION) (K862596)General Devices1986-09-26
MODEL 535 NEO-TRAK RECORDER (K855045)Ge Medical Systems Information Technologies1986-05-16
LONG TERM RECORDER RAG 1200 (K854866)Nihon Kohden America, Inc.1986-04-09
SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 (K851625)Eaton Medical Group1985-11-19
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL (K852487)Fukuda Denshi USA, Inc.1985-09-19
SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE (K851626)Eaton Medical Group1985-06-26
OHMEDA MODEL 0001/0003 RECORDER (K851274)Ohmeda Medical1985-05-15
RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE (K850365)Eaton Medical Group1985-04-09
NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER (K850487)Novametrix Medical Systems, Inc.1985-03-29
SIREDOC, PAPER CHART RECORDER (K850146)Siemens Medical Solutions USA, Inc.1985-02-12
THERMAL GRAYSCALE RF-100 (K843836)Fukuda Denshi USA, Inc.1984-10-19
I-CHANNEL RECORDER (K833000)Litton Medical Electronics1984-06-01
2-CHANNEL RECORDER (K832998)Litton Medical Electronics1984-06-01
NARCOTRACE 40 - NT40 (K833656)Narco Bio-Systems1984-05-09
MONITORING SYSTEM AS100-AS115 RECORD (K832754)Air-Shields, Inc.1983-12-22
PHOENIX 60/60 PROCESSOR MODULE (K831134)Phoenix Corp.1983-11-07
MEDICAL ELECTRONICS-PRINTER CLOCK (K832012)Litton Medical Electronics1983-10-31
VENTURE II MONITORING SYSTEM (K830321)Rae Medical Corp.1983-06-03
DUAL CHANNEL RECORDER #78574A (K830315)Hewlett-Packard Co.1983-03-31
MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3 (K822978)Siemens Corp.1982-12-15
MINGOCARD 7 & MINGOPHONE 7 (K822983)Siemens Corp.1982-11-24
MODEL 525 NEO-TRAK NEONATAL RECORDER (K823210)Ge Medical Systems Information Technologies1982-11-24
CENTURION CHART RECORDER (K822432)Clinical Data, Inc.1982-11-01
MODEL 16800 TREND RECORDER (K821612)Healthdyne, Inc.1982-07-14
EVENTMASTER 3 HOLTER EVENT SCANNER (K821173)Instruments For Cardiac Research1982-05-18
CARDIOVUE ACCESSORY CART (K820033)Diasonics, Inc.1982-01-22
VASCULAB #R12B (K812608)Medasonics, Inc.1981-10-02
SPACELABS' SYSTEM AUTORECORDER (K811540)Spacelabs, Inc.1981-08-13
PAPER CHART RECORDER (K811254)American Edwards Laboratories1981-07-10
NOVATRACER RECORDER (K811453)Novametrix Medical Systems, Inc.1981-07-10
1,2,3 CHANNELL RECORDERS (AR150,AR250,-) (K810166)Honeywell, Inc.1981-02-25
CENTRAL STATION CONTROLLER AC100/CE100 (K810169)Honeywell, Inc.1981-02-25
SINGLE CHANNELL RECORDER AR110 (K810167)Honeywell, Inc.1981-02-25
ADVANCEMED EXAMINER (K803225)American Edwards Laboratories1981-01-13
MODEL 9300 ELECTROCARDIOVALIDATOR (K801830)Del Mar Avionics1980-08-27
MODEL R11 SINGLE CHANNEL CHART RECORDER (K801549)Medasonics, Inc.1980-07-14
SERIES 602 CKG RECORDER (MODIFIED) (K801485)Cardio Kinetics, Inc.1980-07-08
SERIES 602 CKGTM RECORDER (K800851)Cardio Kinetics, Inc.1980-04-24
50MM WRITER MODEL CVM 9529 (K792099)C-V Monitors Corp.1979-10-26
CRITIKON DUAL CHANNEL RECORDER (K792105)Critikon Company, LLC1979-10-26
LS-8 VISICORDER (K790825)Honeywell, Inc.1979-05-31
RECORDER, STRIP CHART WITH PRINTER (K781873)Midwest Analog & Digital, Inc.1979-01-05
WRITER, GEMINI-3 (K781867)C-V Monitors Corp.1979-01-05
PRINTER, DIGITAL (K781115)Output, Inc.1978-10-06
ECG PAPER, 3 CHANNEL (K780597)Abco Dealers, Inc.1978-06-28
4600 RECORDER (K780677)G & W Applied Science Laboratories1978-05-17
DRY SILVER PROCESSOR MODEL 1226 (K780640)Honeywell, Inc.1978-04-28
RECORDER, RE-100P HOT STYLUS STRIP CHART (K780245)Waters Assoc., Inc.1978-03-27
MINYSTAG MN-1 (K780338)Lkb Instruments, Inc.1978-03-15
RECORDER, PAPER, ECG (K772333)Telectronics, Inc.1978-02-13
PHYSIOLOGICAL RECORDER MODEL 740 (K772054)Datascope Corp.1977-11-22
PHYSIOLOGICAL RECORDER MODEL 721A (K772052)Datascope Corp.1977-11-22
SINGLE & DUAL CHANNEL RECORDER (K772048)Hewlett-Packard Co.1977-11-09
SYSTEM II (K771372)Irex Corp.1977-08-04
RECORD, MODEL 702, I.L. (K770946)Instrumentation Laboratory CO1977-07-05
RECORDER, CHART, MODEL 5536 (K770342)Hudson Oxygen Therapy Sales Co.1977-03-01
TREND ANALYZER (K761077)Eldeco1976-12-28
CALCULATOR PLOTTER (MODEL 9872A) (K761055)Hewlett-Packard Co.1976-12-09
LIFEPAK 5 CARDIOSCOPE-RECORDER MODULE (K760676)Physio-Control Corp.1976-10-13
RECORDER (#78640A) (K760539)Hewlett-Packard Co.1976-09-09

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