Innovative Diagnostic Systems, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Innovative Diagnostic Systems, Inc.” (first 1981, latest 1996), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 3 | 3 |
| JSP | Kit, Anaerobic Identification | 2 | 2 |
| JSS | Kit, Identification, Enterobacteriaceae | 2 | 2 |
| JSW | Kit, Identification, Glucose Nonfermenter | 1 | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 | 1 |
| JXB | Kit, Identification, Yeast | 1 | 1 |
Review panels
- Microbiology (11)
Most recent Innovative Diagnostic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962966 | IDS RAPID CB PLUS SYSTEM | JTO | 1996-10-08 | 70 |
| K943621 | RAPID YEAST PLUS SYSTEM | JXB | 1995-01-27 | 184 |
| K900517 | RAPID NF SYSTEM | JSW | 1990-03-13 | 39 |
| K882960 | IDS RAPID ANA SYSTEM | JSP | 1988-08-12 | 29 |
| K881501 | MODIFIED IDS RAPID NH SYSTEM | JSX | 1988-05-18 | 37 |
| K852871 | IDS RAPID SS/U SYSTEM | JSS | 1985-07-23 | 15 |
| K852110 | IDS RAPID E PLUS SYSTEM | JSS | 1985-06-04 | 20 |
| K833654 | IDS RAPID STR SYSTEM | JTO | 1984-02-13 | 116 |
| K822144 | IDS STAPHYLOCHROME TEST | JWX | 1982-08-24 | 34 |
| K820483 | IDA RAPID O2A SYSTEM | JSP | 1982-03-15 | 21 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Innovative Diagnostic Systems, Inc..
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.
- Innovative Health, LLC (50 510(k)s)
- Innovative Medical Systems, Inc. (22 510(k)s)
- Innovative Technologies , Ltd. (14 510(k)s)
- Innovative Surgical Products, Inc. (12 510(k)s)
- Innovative Gloves Co;, Ltd. (9 510(k)s)
- Innovative Surgical Designs, Inc. (9 510(k)s)
- Innovative Bioceramix, Inc. (8 510(k)s)
- Innovative Surgical, Inc. (7 510(k)s)
- Innovative Medical Technologies, Inc. (6 510(k)s)
- Innovative Spinal Technologies, Inc. (4 510(k)s)
- Innovative Therapies, Inc. (4 510(k)s)
- Innovative Trauma Care, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innovative Diagnostic Systems, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Innovative Diagnostic Systems, Inc.” (first 1981, latest 1996), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Innovative Diagnostic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innovative Diagnostic Systems, Inc. is 34 days.
Which FDA product codes appear under Innovative Diagnostic Systems, Inc.?
The most frequent FDA product codes under this applicant name are JTO (Discs, Strips And Reagents, Microorganism Differentiation, 3); JSP (Kit, Anaerobic Identification, 2); JSS (Kit, Identification, Enterobacteriaceae, 2).
Next steps
- See all 11 Innovative Diagnostic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTO, Innovative Diagnostic Systems, 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.