Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LHD — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
130 daysmedian FDA review time
461 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200163 | Ava Fertility Tracker | Ava AG | 2021-01-19 | 363 | 0 |
| K122337 | OVUSENSE | Fertility Focus, Ltd. | 2013-08-06 | 369 | 0 |
| K102499 | DUOFERTILITY | Cambridge Temperature Concepts , Ltd. | 2011-12-20 | 476 | 0 |
| K050094 | LADY COMP USA | Lady Comp USA | 2006-04-20 | 461 | 0 |
| K030961 | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 | Microlife Corp. | 2003-09-12 | 169 | 0 |
| K021978 | PETIT SOPHIA | Nishitomo Co., Inc. | 2003-04-08 | 295 | 0 |
| K002726 | TCOYF FERTILITY SOFTWARE VERSION 1.0 | Ovusoft, LLC | 2001-04-06 | 218 | 0 |
| K952756 | MEDI-AID BASAL THERMOMETER | Polymedica Industries, Inc. | 1995-09-25 | 101 | 0 |
| K945427 | B-D DIGITAL THERMOMETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-06-15 | 223 | 0 |
| K904211 | BIOSELF 2000 FERTILITY INDICATOR | Bioself, Inc. | 1992-10-14 | 763 | 0 |
| K901512 | L SOPHIA | Nishitomo Co., Inc. | 1990-07-20 | 113 | 0 |
| K880618 | FERTILITY FORECASTER COMPUTER PROGRAM | Fertile Time, Ltd. | 1988-06-24 | 129 | 0 |
| K870999 | GENDER CHOICE INFORMATION KIT, FEMALE AND MALE | Procare C/O Wiley, Rein & Fielding | 1987-07-14 | 125 | 0 |
| K870528 | OVU-TRAC OVULATION TIMING KIT | Ob/Gyn Concepts, Ltd. | 1987-05-06 | 90 | 0 |
| K852194 | MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET | Sharp Electronics Corp. | 1985-09-27 | 130 | 0 |
| K852801 | BIOCHRON FERTILITY INDICATOR | Fertil-A-Chron, Inc. | 1985-09-19 | 80 | 0 |
| K845009 | RABBIT-PERSONAL COMPUTER FOR WOMEN | Sanimor, Inc. | 1985-04-10 | 105 | 0 |
| K844043 | OVUDATE | Joel R.L. Ehren Kranz | 1985-02-15 | 121 | 0 |
| K843699 | BIOSELF TM 110 | Bioself, Inc. | 1984-12-04 | 75 | 0 |
| K823463 | RIGHT TIME RHYTHM CLOCK | P.K. Morgan Instruments, Inc. | 1983-03-17 | 118 | 0 |
| K823209 | BIOSELF 101 | Bioself, Inc. | 1983-02-15 | 110 | 0 |
| K821507 | SYMPTOTHERM 8 FERTILITY INDICATOR | Ovix Corp., Inc. | 1982-10-14 | 147 | 0 |
| K813497 | RHYTHM WHEEL | Tropical Enterprises, Inc. | 1982-05-03 | 140 | 0 |
| K810832 | FORECASTER | Forecaster Co. | 1981-06-24 | 91 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda