Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Irvine Scientific Sales Co., Inc. · Predicate Candidate Screening
40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
148 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171224 | Arctic Sperm Cryopreservation Medium | Irvine Scientific Sales Co., Inc. | 2017-08-31 | 127 | 0 |
| K170681 | Continuous Single Culture -NX (CSCM-NX) | Irvine Scientific Sales Co., Inc. | 2017-06-08 | 94 | 0 |
| K170602 | Continuous Single Culture-NX Complete (CSCM-NXC) | Irvine Scientific Sales Co., Inc. | 2017-06-07 | 98 | 0 |
| K121572 | CONTINUOUS SINGLE CULTURE COMPLETE | Irvine Scientific Sales Co., Inc. | 2012-07-19 | 51 | 0 |
| K121128 | MULTIPURPOSE HANDLING MEDIUM | Irvine Scientific Sales Co., Inc. | 2012-06-06 | 54 | 0 |
| K093273 | VIT KIT - FREEZE AND THAW | Irvine Scientific Sales Co., Inc. | 2010-03-03 | 135 | 0 |
| K072609 | SINGLE STEP MEDIUM | Irvine Scientific Sales Co., Inc. | 2008-02-12 | 148 | 0 |
| K072608 | LYOPHILIZED MULTIBLAST MEDIUM KIT | Irvine Scientific Sales Co., Inc. | 2008-01-30 | 135 | 0 |
| K072607 | LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT | Irvine Scientific Sales Co., Inc. | 2008-01-25 | 130 | 0 |
| K061549 | AMNIOSTAT-FLM-PG | Irvine Scientific Sales Co., Inc. | 2006-10-18 | 135 | 0 |
| K061679 | WALLACE ARTIFICIAL INSEMINATION CATHETER | Irvine Scientific Sales Co., Inc. | 2006-10-13 | 120 | 0 |
| K060168 | VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT | Irvine Scientific Sales Co., Inc. | 2006-04-24 | 91 | 0 |
| K041562 | CRYOTIP | Irvine Scientific Sales Co., Inc. | 2004-08-09 | 60 | 0 |
| K034063 | MULTIBLAST MEDIUM | Irvine Scientific Sales Co., Inc. | 2004-04-26 | 117 | 0 |
| K033462 | EARLY CLEAVAGE MEDIUM (ECM) | Irvine Scientific Sales Co., Inc. | 2004-01-15 | 76 | 0 |
| K032887 | PHENOL RED STOCK SOLUTION | Irvine Scientific Sales Co., Inc. | 2003-12-19 | 94 | 0 |
| K022931 | HYALURONIDASE SOLUTION | Irvine Scientific Sales Co., Inc. | 2002-11-04 | 61 | 0 |
| K021358 | EMBRYO BIOPSY MEDIUM | Irvine Scientific Sales Co., Inc. | 2002-07-05 | 67 | 0 |
| K013518 | EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM | Irvine Scientific Sales Co., Inc. | 2002-01-18 | 87 | 0 |
| K011938 | OIL FOR EMBRYO CULTURE | Irvine Scientific Sales Co., Inc. | 2001-07-18 | 27 | 1 |
| K011598 | WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE | Irvine Scientific Sales Co., Inc. | 2001-06-13 | 20 | 0 |
| K003278 | COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPL | Irvine Scientific Sales Co., Inc. | 2001-01-17 | 90 | 0 |
| K003448 | DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301 | Irvine Scientific Sales Co., Inc. | 2000-12-07 | 31 | 0 |
| K000309 | BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM | Irvine Scientific Sales Co., Inc. | 2000-03-13 | 41 | 0 |
| K991339 | TYRODE'S SOLUTION-ACIDIFIED | Irvine Scientific Sales Co., Inc. | 1999-12-06 | 231 | 0 |
| K991419 | MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL | Irvine Scientific Sales Co., Inc. | 1999-09-14 | 144 | 0 |
| K991338 | BOVINE SERUM ALBUMIN (BSA) | Irvine Scientific Sales Co., Inc. | 1999-07-14 | 86 | 0 |
| K991343 | PVP (POLYVINYLPYRROLIDONE) | Irvine Scientific Sales Co., Inc. | 1999-07-14 | 86 | 0 |
| K991342 | PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION | Irvine Scientific Sales Co., Inc. | 1999-07-08 | 80 | 0 |
| K991337 | SPERM MAINTENANCE MEDIUM WITH GLYCEROL | Irvine Scientific Sales Co., Inc. | 1999-07-08 | 80 | 0 |
| K991341 | ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION | Irvine Scientific Sales Co., Inc. | 1999-07-08 | 80 | 1 |
| K991420 | MODIFIED HAM'S F-10 WITH ALBUMIN | Irvine Scientific Sales Co., Inc. | 1999-07-02 | 70 | 0 |
| K991421 | FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFR | Irvine Scientific Sales Co., Inc. | 1999-07-02 | 70 | 0 |
| K983588 | SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM | Irvine Scientific Sales Co., Inc. | 1999-04-26 | 195 | 0 |
| K983579 | SYNTHETIC SERUM SUBSTITUTE (SSS) | Irvine Scientific Sales Co., Inc. | 1999-04-23 | 192 | 0 |
| K983586 | HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT | Irvine Scientific Sales Co., Inc. | 1999-02-18 | 128 | 0 |
| K983589 | P-1 (PREIMPLANTATION STAGE ONE) MEDIUM | Irvine Scientific Sales Co., Inc. | 1999-02-18 | 128 | 0 |
| K983580 | BLASTOCYST MEDIUM | Irvine Scientific Sales Co., Inc. | 1999-02-18 | 128 | 0 |
| K983584 | HUMAN SERUM ALBUMIN (HSA) | Irvine Scientific Sales Co., Inc. | 1999-02-08 | 118 | 0 |
| K971809 | ISOLATE | Irvine Scientific Sales Co., Inc. | 1997-07-03 | 49 | 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