Quantitative Medicine, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Quantitative Medicine, Inc.” (first 1984, latest 1997), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 162 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 3 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- Neurology (3)
- Obstetrics and Gynecology (2)
- Clinical Chemistry (1)
- Cardiovascular (1)
- Physical Medicine (1)
Most recent Quantitative Medicine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963608 | QUANTITATIVE SENTINEL SYSTEM | HGM | 1997-03-11 | 182 |
| K960109 | QUANTITATIVE SENTINEL SYSTEM | HGM | 1996-08-01 | 203 |
| K923255 | Q-SD | GZJ | 1992-10-05 | 95 |
| K912462 | Q-MS NEUROMUSCULAR STIMULATOR | IPF | 1992-06-04 | 366 |
| K912463 | MICRO-Q | GZJ | 1991-11-13 | 162 |
| K912460 | Q-TENS | GZJ | 1991-11-13 | 162 |
| K904603 | QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM | CEK | 1991-01-25 | 107 |
| K833395 | SENTINEL SYSTEMS | DXG | 1984-01-10 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Quantitative Medicine, 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.
- Quantitative Technologies, Inc. (2 510(k)s)
- Quantitative Insights, Inc. (1 510(k)s)
- Quantitative (1 510(k)s)
- Quantitative Cardiac Systems (Qcs), Inc. (1 510(k)s)
- Quantitative Radiology Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quantitative Medicine, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Quantitative Medicine, Inc.” (first 1984, latest 1997), across 5 product codes in 5 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 Quantitative Medicine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quantitative Medicine, Inc. is 162 days.
Which FDA product codes appear under Quantitative Medicine, Inc.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 3); HGM (System, Monitoring, Perinatal, 2); CEK (Biuret (Colorimetric), Total Protein, 1).
Next steps
- See all 8 Quantitative Medicine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Quantitative Medicine, 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.