Atlas FDA

LHD

24 FDA 510(k) clearances · Product code

130 daysmedian time to decision
461 days90th percentile
24clearances measured

FDA profile

Official device name
Device, Fertility Diagnostic, Proceptive
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Ava Fertility Tracker (K200163)Ava AG2021-01-19
OVUSENSE (K122337)Fertility Focus, Ltd.2013-08-06
DUOFERTILITY (K102499)Cambridge Temperature Concepts , Ltd.2011-12-20
LADY COMP USA (K050094)Lady Comp USA2006-04-20
MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 (K030961)Microlife Corp.2003-09-12
PETIT SOPHIA (K021978)Nishitomo Co., Inc.2003-04-08
TCOYF FERTILITY SOFTWARE VERSION 1.0 (K002726)Ovusoft, LLC2001-04-06
MEDI-AID BASAL THERMOMETER (K952756)Polymedica Industries, Inc.1995-09-25
B-D DIGITAL THERMOMETER (K945427)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-06-15
BIOSELF 2000 FERTILITY INDICATOR (K904211)Bioself, Inc.1992-10-14
L SOPHIA (K901512)Nishitomo Co., Inc.1990-07-20
FERTILITY FORECASTER COMPUTER PROGRAM (K880618)Fertile Time, Ltd.1988-06-24
GENDER CHOICE INFORMATION KIT, FEMALE AND MALE (K870999)Procare C/O Wiley, Rein & Fielding1987-07-14
OVU-TRAC OVULATION TIMING KIT (K870528)Ob/Gyn Concepts, Ltd.1987-05-06
MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET (K852194)Sharp Electronics Corp.1985-09-27
BIOCHRON FERTILITY INDICATOR (K852801)Fertil-A-Chron, Inc.1985-09-19
RABBIT-PERSONAL COMPUTER FOR WOMEN (K845009)Sanimor, Inc.1985-04-10
OVUDATE (K844043)Joel R.L. Ehren Kranz1985-02-15
BIOSELF TM 110 (K843699)Bioself, Inc.1984-12-04
RIGHT TIME RHYTHM CLOCK (K823463)P.K. Morgan Instruments, Inc.1983-03-17
BIOSELF 101 (K823209)Bioself, Inc.1983-02-15
SYMPTOTHERM 8 FERTILITY INDICATOR (K821507)Ovix Corp., Inc.1982-10-14
RHYTHM WHEEL (K813497)Tropical Enterprises, Inc.1982-05-03
FORECASTER (K810832)Forecaster Co.1981-06-24

Track LHD automatically

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