510(k) Report

FDA applicant

Irvine Scientific Sales Co., Inc.

Santa Ana, CA40 decisions1997–20172 recalls

FDA records 40 decisions for Irvine Scientific Sales Co., Inc. (Santa Ana, CA) from 1997 to 2017: 40 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MTW (System, Water, Reproduction, Assisted, And…). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 10 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Irvine Scientific Sales Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2017

2008: 32010: 12012: 22017: 3
2007high 3 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2023

2023: 2
2007high 2 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Irvine Scientific Sales Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Irvine Scientific Sales Co., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQLMedia, Reproductive36decisions
  • MTWSystem, Water, Reproduction, Assisted, And Purification1decision
  • JHGChromatographic Separation, Lecithin/Sphingomyelin Ratio1decision
  • LKFCannula, Manipulator/Injector, Uterine1decision
  • MQHMicrotools, Assisted Reproduction (Pipettes)1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 98 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 25 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060168Vitrification Freeze Kit, Vitrification Thaw KitIrvine Scientific Sales Co., Inc. · 20067cite it
  • K041562CryotipIrvine Scientific Sales Co., Inc. · 20044cite it
  • K121572Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 20123cite it
  • K983586HTF Medium, Modified HTF Medium- Hepes, HTF Powder (Without Antibiotics), Modified HTG Powder- Hepes…Irvine Scientific Sales Co., Inc. · 19993cite it
  • K000309Blastocyst Freeze Medium, Blastocyst Thaw MediumIrvine Scientific Sales Co., Inc. · 20002cite it
  • K991343PVP (Polyvinylpyrrolidone)Irvine Scientific Sales Co., Inc. · 19992cite it

What has FDA decided for it lately?

  • K171224Arctic Sperm Cryopreservation MediumIrvine Scientific Sales Co., Inc. · 2017
  • K170681Continuous Single Culture -NX (CSCM-NX)Irvine Scientific Sales Co., Inc. · 2017
  • K170602Continuous Single Culture-NX Complete (CSCM-NXC)Irvine Scientific Sales Co., Inc. · 2017
  • K121572Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc. · 2012
  • K121128Multipurpose Handling MediumIrvine Scientific Sales Co., Inc. · 2012
  • K093273Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc. · 2010
  • K072609Single Step MediumIrvine Scientific Sales Co., Inc. · 2008
  • K072608Lyophilized Multiblast Medium KitIrvine Scientific Sales Co., Inc. · 2008

All 40 as Irvine Scientific Sales Co., Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K991341Sperm separation media are used to separate motile sperm from other constituents of semen.Nov 2, 2023Class II
  • K011938Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305Jan 16, 2023Class II

Other applicant names beginning “Irvine”

FDA records each applicant name separately; these may or may not be the same firm.

Irvine Scientific 16Irvine Biomedical, Inc. 13Irvine Diagnostic Services 10Irvine Biomedical,Inc.(Ibi) 2Irvine Biomedical, A St. Jude Medical Company 2