510(k) Report

FDA applicant

Fujifilm Irvine Scientific

Santa Ana, CA5 decisions2019–20250 recalls

FDA records 5 decisions for Fujifilm Irvine Scientific (Santa Ana, CA) from 2019 to 2025: 5 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and NDS (Media, Culture, Ex Vivo, Tissue And Cell). Since 2016 its 510(k)s took a median of 147 days from receipt to decision, against 183 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Fujifilm Irvine Scientific, Inc.”.

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 Fujifilm Irvine Scientific’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12023: 12024: 22025: 1
2019high 2 (2024) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Fujifilm Irvine Scientific by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fujifilm Irvine Scientific’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, Reproductive3decisions
  • NDSMedia, Culture, Ex Vivo, Tissue And Cell1decision
  • MQKLabware, Assisted Reproduction1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 147 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 183 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K190152Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 20192cite it

What has FDA decided for it lately?

  • K250445Fast Warm - NXFujifilm Irvine Scientific · 2025
  • K241341cryo-GO Vitrification DeviceFujifilm Irvine Scientific · 2024
  • K233764SSS-NX (Serum Substitute Supplement-NX)Fujifilm Irvine Scientific · 2024
  • K231804PRIME-XV FreezIS DMSO-Free MDFujifilm Irvine Scientific · 2023
  • K190152Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc. · 2019

All 4 as Fujifilm Irvine Scientific →The one decision as Fujifilm Irvine Scientific, Inc. →

Other applicant names beginning “Fujifilm”

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

Fujifilm Medical System U.S.A., Inc. 72Fujifilm Corporation 71Fujifilm Medical Systems U.S.A, Inc. 40FUJIFILM Sonosite, Inc. 25FUJIFILM Healthcare Americas Corporation 13Fujifilm Healthcare Corporation 6Fujifilm Corporaton 6Fujifilm New Development U.S.A., Inc. 3Fujifilm Medwork GmbH 2Fujifilm Meidcal Systems U.S.A.,Inc. 2