Diamond Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Diamond Medical, Inc.” (first 1987, latest 1992), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| FFT | Electrode, Ph, Stomach | 4 | 4 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 | 2 |
Review panels
Most recent Diamond Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924758 | DMI BLOOD GAS ANALYZER/CARTRIDGE | CHL | 1992-12-03 | 71 |
| K915087 | DMI BLOD GAS ANALYZER/CARTRIDGE | CHL | 1992-01-08 | 57 |
| K874710 | DIAMOND MEDICAL, INC. MODEL DM 600 | FFT | 1988-02-08 | 88 |
| K874709 | DIAMOND MEDICAL, INC. MODEL DM 800 | FFT | 1988-02-08 | 88 |
| K875369 | MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT | FFT | 1988-02-05 | 36 |
| K863298 | DIAMOND MEDICAL, INC., MODEL DM 700 | FFT | 1987-03-17 | 204 |
Recalls
openFDA lists no recalls under a recalling firm named Diamond Medical, 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.
- Diamond Diagnostics, Inc. (26 510(k)s)
- Diamond Medical Equipment, Inc. (3 510(k)s)
- Diamond Sensor Systems (3 510(k)s)
- Diamond Shamrock Corp. (2 510(k)s)
- Diamond Age Systems, Inc. (1 510(k)s)
- Diamond Brothers Trading Co., Inc. (1 510(k)s)
- Diamond Electro-Tech, Inc. (1 510(k)s)
- Diamond Mark International Co., Ltd. (1 510(k)s)
- Diamond Orthopedic, LLC (1 510(k)s)
- Diamond Orthotic Laboratory (1 510(k)s)
- Diamond Rotary and Carbide Intl. (1 510(k)s)
- Diamond Systems USA, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diamond Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Diamond Medical, Inc.” (first 1987, latest 1992), across 2 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 Diamond Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diamond Medical, Inc. is 80 days.
Which FDA product codes appear under Diamond Medical, Inc.?
The most frequent FDA product codes under this applicant name are FFT (Electrode, Ph, Stomach, 4); CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 2).
Next steps
- See all 6 Diamond Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FFT, Diamond Medical, 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.