Product Code: LHD FDA unclassified

Device, Fertility Diagnostic, Proceptive

Unknown

A proceptive fertility diagnostic device is a tool designed to assist individuals or couples in identifying the fertile window in the menstrual cycle, supporting attempts to achieve pregnancy by indicating optimal timing for intercourse. This device is currently unclassified by the FDA, meaning a formal risk classification has not yet been established through the regulatory rulemaking process. It carries product code LHD and no regulation number or medical specialty has been officially assigned. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LHD
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: OB
Submission Type: 7

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K200163	Ava Fertility Tracker	Jan 19, 2021	Substantially Equivalent	Ava AG
K122337	OVUSENSE	Aug 06, 2013	Substantially Equivalent	Fertility Focus, Ltd.
K102499	DUOFERTILITY	Dec 20, 2011	Substantially Equivalent	Cambridge Temperature Concepts , Ltd.
K050094	LADY COMP USA	Apr 20, 2006	Substantially Equivalent	Lady Comp USA
K030961	MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921	Sep 12, 2003	Substantially Equivalent	Microlife Corp.
K021978	PETIT SOPHIA	Apr 08, 2003	Substantially Equivalent	Nishitomo Co., Inc.
K002726	TCOYF FERTILITY SOFTWARE VERSION 1.0	Apr 06, 2001	Substantially Equivalent	Ovusoft, LLC
K952756	MEDI-AID BASAL THERMOMETER	Sep 25, 1995	Substantially Equivalent	Polymedica Industries, Inc.
K945427	B-D DIGITAL THERMOMETER	Jun 15, 1995	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K904211	BIOSELF 2000 FERTILITY INDICATOR	Oct 14, 1992	Substantially Equivalent	Bioself, Inc.
K901512	L SOPHIA	Jul 20, 1990	Substantially Equivalent	Nishitomo Co., Inc.
K880618	FERTILITY FORECASTER COMPUTER PROGRAM	Jun 24, 1988	Substantially Equivalent	Fertile Time, Ltd.
K870999	GENDER CHOICE INFORMATION KIT, FEMALE AND MALE	Jul 14, 1987	Substantially Equivalent	Procare C/O Wiley, Rein & Fielding
K870528	OVU-TRAC OVULATION TIMING KIT	May 06, 1987	Substantially Equivalent	Ob/Gyn Concepts, Ltd.
K852194	MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET	Sep 27, 1985	Substantially Equivalent	Sharp Electronics Corp.
K852801	BIOCHRON FERTILITY INDICATOR	Sep 19, 1985	Substantially Equivalent	Fertil-A-Chron, Inc.
K845009	RABBIT-PERSONAL COMPUTER FOR WOMEN	Apr 10, 1985	Substantially Equivalent	Sanimor, Inc.
K844043	OVUDATE	Feb 15, 1985	Substantially Equivalent	Joel R.L. Ehren Kranz
K843699	BIOSELF TM 110	Dec 04, 1984	Substantially Equivalent	Bioself, Inc.
K823463	RIGHT TIME RHYTHM CLOCK	Mar 17, 1983	Substantially Equivalent	P.K. Morgan Instruments, Inc.
K823209	BIOSELF 101	Feb 15, 1983	Substantially Equivalent	Bioself, Inc.
K821507	SYMPTOTHERM 8 FERTILITY INDICATOR	Oct 14, 1982	Substantially Equivalent	Ovix Corp., Inc.
K813497	RHYTHM WHEEL	May 03, 1982	Substantially Equivalent	Tropical Enterprises, Inc.
K810832	FORECASTER	Jun 24, 1981	Substantially Equivalent	Forecaster Co.