Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
<Genx> Intl., Inc. — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
227 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HT | <Genx> Intl., Inc. | 2012-05-03 | 287 | 0 |
| K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING | Genx Intl., Inc. | 2011-01-14 | 476 | 0 |
| K092667 | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT | Genx Intl., Inc. | 2010-06-03 | 276 | 0 |
| K092578 | LIFEGLOBAL PROTEIN SUPPLEMENT | Genx Intl., Inc. | 2010-04-05 | 227 | 0 |
| K083509 | LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA | Genx Intl., Inc. | 2009-04-24 | 149 | 0 |
| K080395 | SUNIVF DISHES | <Genx> Intl., Inc. | 2008-08-13 | 182 | 0 |
| K070689 | LG SPERM FREEZING | Genx Intl., Inc. | 2007-07-03 | 112 | 0 |
| K053552 | GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA | <Genx> Intl., Inc. | 2006-05-19 | 150 | 0 |
| K053551 | MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARA | <Genx> Intl., Inc. | 2006-05-09 | 140 | 0 |
| K040530 | MEDIA CULTURE SYSTEM | <Genx> Intl., Inc. | 2004-06-25 | 116 | 0 |
| K023033 | ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) | <Genx> Intl., Inc. | 2002-11-26 | 75 | 0 |
| K022590 | PVP (POLYVINYLPYRROLIDONE) | <Genx> Intl., Inc. | 2002-08-30 | 25 | 0 |
| K022334 | HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS | <Genx> Intl., Inc. | 2002-08-28 | 41 | 0 |
| K022352 | HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) | <Genx> Intl., Inc. | 2002-08-28 | 40 | 0 |
| K022547 | ACIDIFIED TYRODES SOLUTION | <Genx> Intl., Inc. | 2002-08-28 | 27 | 0 |
| K022330 | ALLGRAD 45 AND 90 CELL SEPARATION MEDIA | <Genx> Intl., Inc. | 2002-08-26 | 39 | 0 |
| K022335 | ALLGRAD AND ALLGRAD100 | <Genx> Intl., Inc. | 2002-08-23 | 36 | 0 |
| K022332 | LITE MINERAL OIL | <Genx> Intl., Inc. | 2002-08-23 | 36 | 0 |
| K020560 | WORKBENCH BY <GENX> | Genx Intl., Inc. | 2002-06-19 | 119 | 0 |
| K010183 | GLOBAL BY <GENX> BLASTOCYST MEDIA | <Genx> Intl., Inc. | 2001-05-02 | 103 | 0 |
| K001600 | <GENX> CODA INCUBATOR CELLMATE | <Genx> Intl., Inc. | 2000-11-22 | 182 | 0 |
| K001486 | GENX CODA AIR PURIFICATION SYSTEM | <Genx> Intl., Inc. | 2000-09-15 | 126 | 0 |
| K993881 | GENX CULTURE DISH | <Genx> Intl., Inc. | 2000-02-14 | 90 | 0 |
| K993884 | GENX MICROTOOLS | <Genx> Intl., Inc. | 2000-02-14 | 90 | 0 |
| K991262 | <GEN>SINGLE LUMEN NEEDLE | <Genx> Intl., Inc. | 1999-09-09 | 149 | 0 |
| K991264 | <GENX> SINGLE LUMEN SIDEPORT NEEDLE | <Genx> Intl., Inc. | 1999-09-09 | 149 | 0 |
| K991020 | <GENX> DOUBLE LUMEN NEEDLE | <Genx> Intl., Inc. | 1999-09-09 | 164 | 0 |
| K991022 | <GENX> SPERM WASHING MEDIA | <Genx> Intl., Inc. | 1999-09-09 | 164 | 0 |
| K991266 | <GENX> EMBRYO TRANSFER CATHETER CC GLIDER | <Genx> Intl., Inc. | 1999-09-09 | 149 | 0 |
| K991173 | <GENX> FERTILIZATION MEDIA-HTF | <Genx> Intl., Inc. | 1999-07-19 | 103 | 0 |
| K962816 | SPERM PREPARATION MEDIA | Genx Intl., Inc. | 1996-11-26 | 130 | 0 |
| K963031 | GENXCATHETER | Genx Intl., Inc. | 1996-10-21 | 77 | 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