Monitor Science Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Monitor Science Corp.” (first 1977, latest 1979), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 66 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| DID | Bacillus Subtilis Microbiology Assay, Tobramycin | 1 | 1 |
| DKD | Bacillus Subtilis, Microbiological Assay, Gentamicin | 1 | 1 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| KJI | Radioimmunoassay, Kanamycin | 1 | 1 |
| KLP | Amikacin Serum Assay | 1 | 1 |
Review panels
Most recent Monitor Science Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K790580 | RIA KIT, PROSTATIC ACID | JFH | 1979-05-25 | 59 |
| K780951 | BIO-MONITOR GENTAMICIN | DKD | 1978-08-14 | 66 |
| K780950 | BIO-MONITOR TOBRAMYCIN | DID | 1978-08-14 | 66 |
| K780949 | BIO-MONITOR AMIKACIN | KLP | 1978-08-14 | 66 |
| K772038 | KANAMYCIN RIA | KJI | 1978-01-12 | 76 |
| K772039 | BETA-HCG RIA | JHI | 1977-11-23 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named Monitor Science Corp..
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.
- Monitor Instruments, Inc. (2 510(k)s)
- Monitor Mask, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Monitor Science Corp.?
FDA lists 6 510(k) clearances under the applicant name “Monitor Science Corp.” (first 1977, latest 1979), across 6 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 Monitor Science Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Monitor Science Corp. is 66 days.
Which FDA product codes appear under Monitor Science Corp.?
The most frequent FDA product codes under this applicant name are DID (Bacillus Subtilis Microbiology Assay, Tobramycin, 1); DKD (Bacillus Subtilis, Microbiological Assay, Gentamicin, 1); JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited, 1).
Next steps
- See all 6 Monitor Science Corp. clearances with predicates and recalls
- Run predicate analysis for product code DID, Monitor Science Corp.'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.