Diagnostic Monitoring Software: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Diagnostic Monitoring Software” (first 1992, latest 2014), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 32 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 | 1 | 236 |
| 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 |
|---|---|---|---|
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Diagnostic Monitoring Software 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133014 | DMS 300-2W HOLTER ECG RECORDER | MWJ | 2014-05-19 | 236 |
| K062959 | DMS 300-2, 300-3 AND 300-4 | MWJ | 2006-10-16 | 17 |
| K062088 | PREMIER 11 HOLTER | MLO | 2006-08-25 | 32 |
| K062007 | DMS 300-7 | DSH | 2006-08-16 | 30 |
| K911615 | HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 | DQK | 1992-01-08 | 272 |
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Monitoring Software.
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 Monitoring Software?
FDA lists 5 510(k) clearances under the applicant name “Diagnostic Monitoring Software” (first 1992, latest 2014), across 4 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 Monitoring Software?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Monitoring Software is 32 days.
Which FDA product codes appear under Diagnostic Monitoring Software?
The most frequent FDA product codes under this applicant name are MWJ (Electrocardiograph, Ambulatory (Without Analysis), 2); DQK (Computer, Diagnostic, Programmable, 1); DSH (Recorder, Magnetic Tape, Medical, 1).
Next steps
- See all 5 Diagnostic Monitoring Software clearances with predicates and recalls
- Run predicate analysis for product code MWJ, Diagnostic Monitoring Software'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.