Fujifilm Irvine Scientific: FDA filings under this applicant name
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Fujifilm Irvine Scientific” (first 2019, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 142 days. Since 2017 the median was 142 days, against 183 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Fujifilm Healthcare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 142 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 142 |
| 2024 | 2 | 144 |
| 2025 | 1 | 210 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fujifilm Irvine Scientific took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 3 | 3 |
| MQK | Labware, Assisted Reproduction | 1 | 1 |
| NDS | Media, Culture, Ex Vivo, Tissue And Cell | 1 | 1 |
Review panels
Most recent Fujifilm Irvine Scientific 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250445 | Fast Warm - NX | MQL | 2025-09-12 | 210 |
| K241341 | cryo-GO Vitrification Device | MQK | 2024-09-26 | 136 |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) | MQL | 2024-04-24 | 152 |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | NDS | 2023-11-09 | 142 |
| K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | MQL | 2019-06-21 | 142 |
Recalls
4 product recalls in 3 recall events; 2 initiated in the last five years. Most recent: 2023-11-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Fujifilm Irvine Scientific (4)
- Fujifilm Irvine Scientific, Inc. (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fujifilm Medical System U.S.A., Inc. (71 510(k)s)
- Fujifilm Corporation (70 510(k)s)
- Fujifilm Medical Systems U.S.A, Inc. (39 510(k)s)
- FUJIFILM Sonosite, Inc. (25 510(k)s)
- FUJIFILM Healthcare Americas Corporation (13 510(k)s)
- Fujifilm Corporaton (6 510(k)s)
- Fujifilm Healthcare Corporation (6 510(k)s)
- Fujifilm New Development U.S.A., Inc. (3 510(k)s)
- Fujifilm Medwork GmbH (2 510(k)s)
- Fujifilm Meidcal Systems U.S.A.,Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fujifilm Irvine Scientific?
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Fujifilm Irvine Scientific” (first 2019, latest 2025), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fujifilm Irvine Scientific?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fujifilm Irvine Scientific is 142 days. Since 2017: 142 days, versus 183 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fujifilm Irvine Scientific?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 3); MQK (Labware, Assisted Reproduction, 1); NDS (Media, Culture, Ex Vivo, Tissue And Cell, 1).
Next steps
- See all 5 Fujifilm Irvine Scientific clearances with predicates and recalls
- Run predicate analysis for product code MQL, Fujifilm Irvine Scientific's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.