Sendx Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sendx Medical, Inc.” (first 1997, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 91 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 | 2 | 100 |
| 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 | 4 | 4 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 | 1 |
Review panels
Most recent Sendx Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151639 | ABL80 FLEX and ABL80 FLEX CO-OX | CGA | 2015-12-07 | 172 |
| K151856 | ABL80 FLEX CO-OX with AQURE connectivity | CHL | 2015-08-06 | 29 |
| K080370 | ABL 80 CO-OX SYSTEM | CHL | 2008-07-31 | 170 |
| K051804 | ABL80 FLEX ANALYZER | CHL | 2005-11-01 | 119 |
| K994346 | ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | CHL | 2000-02-01 | 40 |
| K973742 | SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM | CGZ | 1997-12-03 | 63 |
Recalls
7 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2012-06-06.
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 Sendx Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Sendx Medical, Inc.” (first 1997, latest 2015), 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 Sendx Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sendx Medical, Inc. is 91 days.
Which FDA product codes appear under Sendx Medical, Inc.?
The most frequent FDA product codes under this applicant name are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 4); CGA (Glucose Oxidase, Glucose, 1); CGZ (Electrode, Ion-Specific, Chloride, 1).
Next steps
- See all 6 Sendx Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHL, Sendx 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.