Irvine Scientific: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Irvine Scientific” (first 1982, latest 2016), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 70 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 121 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HDR | Cap, Cervical | 9 | 9 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 | 4 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| MFD | Cannula, Intrauterine Insemination | 1 | 1 |
| MQL | Media, Reproductive | 1 | 1 |
Review panels
Most recent Irvine Scientific 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit | MQL | 2016-05-04 | 121 |
| K914541 | SPERM MAINTENANCE MEDIUM WITH GLYCEROL | MFD | 1994-02-03 | 846 |
| K900316 | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES | HDR | 1990-04-16 | 83 |
| K894432 | MODIFIED HAM'S F-10 W/ALBUMIN | HDR | 1989-09-22 | 67 |
| K894405 | HTF WITH ALBUMIN (CATALOG NO. 9994) | HDR | 1989-09-22 | 67 |
| K874668 | SPERM WASHING MEDIUM #9983 & MODIFIED #9984 | HDR | 1988-03-31 | 139 |
| K872203 | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) | HDR | 1987-08-14 | 67 |
| K872088 | FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) | HDR | 1987-08-14 | 74 |
| K872102 | SPERM WASHING MEDIUM #9932 | HDR | 1987-07-16 | 45 |
| K871577 | HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES | HDR | 1987-07-15 | 83 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Irvine Scientific.
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.
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.
- Irvine Scientific Sales Co., Inc. (40 510(k)s)
- Irvine Biomedical, Inc. (11 510(k)s)
- Irvine Diagnostic Services (10 510(k)s)
- Irvine Biomedical,Inc.(Ibi) (1 510(k)s)
- Irvine Biomedical, A St. Jude Medical Company (1 510(k)s)
- Irvine Biomedical, Inc., A St. Jude Medical Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Irvine Scientific?
FDA lists 16 510(k) clearances under the applicant name “Irvine Scientific” (first 1982, latest 2016), across 5 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 Irvine Scientific?
The median time from FDA receipt to decision across 510(k)s cleared under the name Irvine Scientific is 70 days.
Which FDA product codes appear under Irvine Scientific?
The most frequent FDA product codes under this applicant name are HDR (Cap, Cervical, 9); JJY (Multi-Analyte Controls, All Kinds (Assayed), 4); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 1).
Next steps
- See all 16 Irvine Scientific clearances with predicates and recalls
- Run predicate analysis for product code HDR, 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.