Product code LHD
- Device name
- Device, Fertility Diagnostic, Proceptive
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200163 | Ava Fertility Tracker | Ava AG | 2021-01-19 |
| K122337 | OVUSENSE | Fertility Focus, Ltd. | 2013-08-06 |
| K102499 | DUOFERTILITY | Cambridge Temperature Concepts , Ltd. | 2011-12-20 |
| K050094 | LADY COMP USA | Lady Comp USA | 2006-04-20 |
| K030961 | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 | Microlife Corp. | 2003-09-12 |
| K021978 | PETIT SOPHIA | Nishitomo Co., Inc. | 2003-04-08 |
| K002726 | TCOYF FERTILITY SOFTWARE VERSION 1.0 | Ovusoft, LLC | 2001-04-06 |
| K952756 | MEDI-AID BASAL THERMOMETER | Polymedica Industries, Inc. | 1995-09-25 |
| K945427 | B-D DIGITAL THERMOMETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-06-15 |
| K904211 | BIOSELF 2000 FERTILITY INDICATOR | Bioself, Inc. | 1992-10-14 |
| K901512 | L SOPHIA | Nishitomo Co., Inc. | 1990-07-20 |
| K880618 | FERTILITY FORECASTER COMPUTER PROGRAM | Fertile Time, Ltd. | 1988-06-24 |
| K870999 | GENDER CHOICE INFORMATION KIT, FEMALE AND MALE | Procare C/O Wiley, Rein & Fielding | 1987-07-14 |
| K870528 | OVU-TRAC OVULATION TIMING KIT | Ob/Gyn Concepts, Ltd. | 1987-05-06 |
| K852194 | MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET | Sharp Electronics Corp. | 1985-09-27 |
| K852801 | BIOCHRON FERTILITY INDICATOR | Fertil-A-Chron, Inc. | 1985-09-19 |
| K845009 | RABBIT-PERSONAL COMPUTER FOR WOMEN | Sanimor, Inc. | 1985-04-10 |
| K844043 | OVUDATE | Joel R.L. Ehren Kranz | 1985-02-15 |
| K843699 | BIOSELF TM 110 | Bioself, Inc. | 1984-12-04 |
| K823463 | RIGHT TIME RHYTHM CLOCK | P.K. Morgan Instruments, Inc. | 1983-03-17 |
| K823209 | BIOSELF 101 | Bioself, Inc. | 1983-02-15 |
| K821507 | SYMPTOTHERM 8 FERTILITY INDICATOR | Ovix Corp., Inc. | 1982-10-14 |
| K813497 | RHYTHM WHEEL | Tropical Enterprises, Inc. | 1982-05-03 |
| K810832 | FORECASTER | Forecaster Co. | 1981-06-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06430060159860 | Fertile Window | Ouraring Inc. | 2025-11-14 |
| 06430060159877 | Fertile Window | Ouraring Inc. | 2025-11-14 |
| 06430060159983 | Fertile Window | Ouraring Inc. | 2024-11-12 |
| 00194253312512 | Cycle Tracking 4.0 | APPLE INC. | 2024-11-01 |
| 00194253312529 | Cycle Tracking 4.0 | APPLE INC. | 2024-11-01 |
| 06430060159990 | Fertile Window | Ouraring Inc. | 2024-10-28 |
| 04260749840039 | Clue App | BioWink GmbH | 2023-07-27 |
| 04260749840046 | Clue App | BioWink GmbH | 2023-07-27 |
| 04260749840022 | Clue Conceive | BioWink GmbH | 2023-05-14 |
| 04260749840015 | Clue Conceive | BioWink GmbH | 2023-05-14 |
| 07350014630100 | Cycle Tracking | Naturalcycles Nordic AB | 2023-04-19 |
| 07629999894334 | Lady-Comp | Valley Electronics AG | 2022-12-07 |
| 07629999054073 | Daysy | Valley Electronics AG | 2022-12-07 |
| 09120095900274 | femSense Ovulation Tracker | SteadySense GmbH | 2022-10-26 |
| 07640184680464 | Ava Fertility | AVA Sciences-FMTC GmbH | 2022-09-29 |
| 07640184680136 | Ava Fertility | AVA Sciences-FMTC GmbH | 2022-09-21 |
| 00194252845967 | Cycle Tracking 3.0 | APPLE INC. | 2022-07-27 |
| 00194252845974 | Cycle Tracking 3.0 | APPLE INC. | 2022-07-27 |
| 00850003500478 | Beurer | BEURER NORTH AMERICA, L.P. | 2021-10-01 |
| 05060508530107 | OvuSense | VIO HEALTHTECH LIMITED | 2021-07-23 |
| 05060508530114 | OvuSense | VIO HEALTHTECH LIMITED | 2021-07-23 |
| 09120095900021 | femSense Fertility | SteadySense GmbH | 2021-07-15 |
| 06938444982498 | OT80-Beurer Ovulation Predictor and Fertility Tracking Kit | Equinox Biotech Co., Ltd. | 2021-06-30 |
| 09120095900014 | femSense Kinderwunsch | SteadySense GmbH | 2021-05-17 |
| 05060508530091 | OvuSense | VIO HEALTHTECH LIMITED | 2021-05-01 |
| 00850003500560 | OVY by Beurer | BEURER NORTH AMERICA, L.P. | 2020-06-01 |
| 00850003500430 | Beurer | BEURER NORTH AMERICA, L.P. | 2019-12-09 |
| 07290016672213 | TytoHome | TYTO CARE LTD | 2019-01-24 |
| 07290016672183 | Tyto Device | TYTO CARE LTD | 2019-01-24 |
| 07290016672039 | TytoPro | TYTO CARE LTD | 2016-12-22 |