Diagnostic Medical Instruments: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Diagnostic Medical Instruments” (first 1983, latest 1992), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 95 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Diagnostic Medical Instruments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912728 | ALTAIR | DQK | 1992-02-27 | 252 |
| K894285 | DMI PC HOLTER SCANNER | DSI | 1989-09-26 | 95 |
| K871045 | DMI AMBULATORY HOLTER MONITOR | DSH | 1987-05-19 | 63 |
| K830489 | RECORDER DMI | DSH | 1983-05-25 | 99 |
| K830407 | ECLIPSE | DSI | 1983-03-24 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Medical Instruments.
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.
- Diagnostic Products Corp. (324 510(k)s)
- Diagnostic Systems Laboratories, Inc. (94 510(k)s)
- Diagnostic Chemicals, Ltd. (Usa) (77 510(k)s)
- Diagnostic Chemicals , Ltd. (66 510(k)s)
- Diagnostic Reagents, Inc. (66 510(k)s)
- Diagnostic Hybrids, Inc. (36 510(k)s)
- Diagnostic Technology, Inc. (28 510(k)s)
- Diagnostic Solutions, Inc. (26 510(k)s)
- Diagnostic Ultrasound Corp. (16 510(k)s)
- Diagnostic Systems (14 510(k)s)
- Diagnostic Reagent Tech. (10 510(k)s)
- Diagnostic Specialties (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diagnostic Medical Instruments?
FDA lists 5 510(k) clearances under the applicant name “Diagnostic Medical Instruments” (first 1983, latest 1992), across 3 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 Diagnostic Medical Instruments?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Medical Instruments is 95 days.
Which FDA product codes appear under Diagnostic Medical Instruments?
The most frequent FDA product codes under this applicant name are DSH (Recorder, Magnetic Tape, Medical, 2); DSI (Detector And Alarm, Arrhythmia, 2); DQK (Computer, Diagnostic, Programmable, 1).
Next steps
- See all 5 Diagnostic Medical Instruments clearances with predicates and recalls
- Run predicate analysis for product code DSH, Diagnostic Medical Instruments'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.