

# LHD · Device, Fertility Diagnostic, Proceptive

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/OB-misc/LHD

## Overview

- **Product Code:** LHD
- **Device Name:** Device, Fertility Diagnostic, Proceptive
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 24)

Showing 20 most recent of 24 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K200163](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K200163.md) | Ava Fertility Tracker | Ava AG | Jan 19, 2021 | SESE |
| [K122337](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K122337.md) | OVUSENSE | Fertility Focus, Ltd. | Aug 6, 2013 | SESE |
| [K102499](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K102499.md) | DUOFERTILITY | Cambridge Temperature Concepts , Ltd. | Dec 20, 2011 | SESE |
| [K050094](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K050094.md) | LADY COMP USA | Lady Comp USA | Apr 20, 2006 | SESE |
| [K030961](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K030961.md) | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 | Microlife Corp. | Sep 12, 2003 | SESE |
| [K021978](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K021978.md) | PETIT SOPHIA | Nishitomo Co., Inc. | Apr 8, 2003 | SESE |
| [K002726](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K002726.md) | TCOYF FERTILITY SOFTWARE VERSION 1.0 | Ovusoft, LLC | Apr 6, 2001 | SESE |
| [K952756](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K952756.md) | MEDI-AID BASAL THERMOMETER | Polymedica Industries, Inc. | Sep 25, 1995 | SESE |
| [K945427](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K945427.md) | B-D DIGITAL THERMOMETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 15, 1995 | SESE |
| [K904211](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K904211.md) | BIOSELF 2000 FERTILITY INDICATOR | Bioself, Inc. | Oct 14, 1992 | SESE |
| [K901512](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K901512.md) | L SOPHIA | Nishitomo Co., Inc. | Jul 20, 1990 | SESE |
| [K880618](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K880618.md) | FERTILITY FORECASTER COMPUTER PROGRAM | Fertile Time, Ltd. | Jun 24, 1988 | SESE |
| [K870999](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K870999.md) | GENDER CHOICE INFORMATION KIT, FEMALE AND MALE | Procare C/O Wiley, Rein & Fielding | Jul 14, 1987 | SESE |
| [K870528](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K870528.md) | OVU-TRAC OVULATION TIMING KIT | Ob/Gyn Concepts, Ltd. | May 6, 1987 | SESE |
| [K852194](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K852194.md) | MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET | Sharp Electronics Corp. | Sep 27, 1985 | SESE |
| [K852801](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K852801.md) | BIOCHRON FERTILITY INDICATOR | Fertil-A-Chron, Inc. | Sep 19, 1985 | SESE |
| [K845009](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K845009.md) | RABBIT-PERSONAL COMPUTER FOR WOMEN | Sanimor, Inc. | Apr 10, 1985 | SESE |
| [K844043](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K844043.md) | OVUDATE | Joel R.L. Ehren Kranz | Feb 15, 1985 | SESE |
| [K843699](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K843699.md) | BIOSELF TM 110 | Bioself, Inc. | Dec 4, 1984 | SESE |
| [K823463](https://fda.innolitics.com/submissions/OB/OB-misc/LHD/K823463.md) | RIGHT TIME RHYTHM CLOCK | P.K. Morgan Instruments, Inc. | Mar 17, 1983 | SESE |

## Top Applicants

- Bioself, Inc. — 3 clearances
- Nishitomo Co., Inc. — 2 clearances
- Ava AG — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Cambridge Temperature Concepts , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/OB-misc/LHD](https://fda.innolitics.com/submissions/OB/OB-misc/LHD)

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