Irvine Scientific Sales Co., Inc.: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “Irvine Scientific Sales Co., Inc.” (first 1997, latest 2017), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 98 days, against 198 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 |
|---|---|---|
| 2012 | 2 | 52 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 3 | 98 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Irvine Scientific Sales Co., Inc. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 198 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQL | Media, Reproductive | 36 | 36 |
| JHG | Chromatographic Separation, Lecithin/Sphingomyelin Ratio | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 1 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | 1 | 1 |
| MTW | System, Water, Reproduction, Assisted, And Purification | 1 | 1 |
Review panels
Most recent Irvine Scientific Sales Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171224 | Arctic Sperm Cryopreservation Medium | MQL | 2017-08-31 | 127 |
| K170681 | Continuous Single Culture -NX (CSCM-NX) | MQL | 2017-06-08 | 94 |
| K170602 | Continuous Single Culture-NX Complete (CSCM-NXC) | MQL | 2017-06-07 | 98 |
| K121572 | CONTINUOUS SINGLE CULTURE COMPLETE | MQL | 2012-07-19 | 51 |
| K121128 | MULTIPURPOSE HANDLING MEDIUM | MQL | 2012-06-06 | 54 |
| K093273 | VIT KIT - FREEZE AND THAW | MQL | 2010-03-03 | 135 |
| K072609 | SINGLE STEP MEDIUM | MQL | 2008-02-12 | 148 |
| K072608 | LYOPHILIZED MULTIBLAST MEDIUM KIT | MQL | 2008-01-30 | 135 |
| K072607 | LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT | MQL | 2008-01-25 | 130 |
| K061549 | AMNIOSTAT-FLM-PG | JHG | 2006-10-18 | 135 |
30 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-10-23.
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 (16 510(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 Sales Co., Inc.?
FDA lists 40 510(k) clearances under the applicant name “Irvine Scientific Sales Co., Inc.” (first 1997, latest 2017), 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 Sales Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Irvine Scientific Sales Co., Inc. is 90 days. Since 2017: 98 days, versus 198 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Irvine Scientific Sales Co., Inc.?
The most frequent FDA product codes under this applicant name are MQL (Media, Reproductive, 36); JHG (Chromatographic Separation, Lecithin/Sphingomyelin Ratio, 1); LKF (Cannula, Manipulator/Injector, Uterine, 1).
Next steps
- See all 40 Irvine Scientific Sales Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQL, Irvine Scientific Sales Co., Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.