Diametrics Medical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Diametrics Medical, Inc.” (first 1995, latest 2003), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 173 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 3 | 3 |
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | 2 | 2 |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 1 | 1 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 | 1 |
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 | 1 |
Review panels
Most recent Diametrics Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030035 | IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE | JFY | 2003-06-25 | 173 |
| K013938 | IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE | KHP | 2002-01-28 | 61 |
| K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | GAA | 2001-11-16 | 177 |
| K983198 | TRENDCARE CALIBRATOR MODEL SCU 7007 | CCC | 1999-11-23 | 438 |
| K980380 | NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS | GWM | 1999-07-14 | 527 |
| K981270 | IRMA BLOOD ANALYSIS SYSTEM | CGZ | 1998-05-01 | 24 |
| K980523 | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE | CHL | 1998-03-19 | 37 |
| K972314 | PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM | CCC | 1997-12-19 | 182 |
| K974396 | IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE | CHL | 1997-12-18 | 27 |
| K970906 | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR | CBZ | 1997-09-23 | 195 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-07-14.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Diametrics Medical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Diametrics Medical, Inc.” (first 1995, latest 2003), across 8 product codes in 4 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 Diametrics Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diametrics Medical, Inc. is 173 days.
Which FDA product codes appear under Diametrics Medical, Inc.?
The most frequent FDA product codes under this applicant name are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 3); CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling, 2); CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling, 1).
Next steps
- See all 11 Diametrics Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHL, Diametrics 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.