In-Line Diagnostics Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “In-Line Diagnostics Corp.” (first 1995, latest 2000), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 177 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 |
|---|---|---|---|
| MQS | System, Hemodialysis, Access Recirculation Monitoring | 5 | 5 |
| GKF | Instrument, Hematocrit, Automated | 1 | 1 |
| JPI | Device, Hematocrit Measuring | 1 | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 | 1 |
Review panels
Most recent In-Line Diagnostics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001763 | CRIT-LINE MONITOR III (CLM III) | MQS | 2000-12-20 | 191 |
| K992227 | CRIT-LINE MONITOR III (CLM III) | MQS | 1999-07-30 | 28 |
| K983551 | CRIT-SCAN II MONITOR | GKF | 1999-05-27 | 230 |
| K982412 | MODIFICATION OF CRIT-LINE MONITOR III (CLM III) | MQS | 1998-10-09 | 88 |
| K972470 | CRIT-LINE MONITOR (CLMIII) | MQS | 1997-12-11 | 163 |
| K953875 | CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) | MQS | 1996-07-23 | 391 |
| K950942 | CRIT-LINE HEMATOCRIT ALERT | JPI | 1995-03-14 | 27 |
| K935958 | CRIT-LINE BLOOD CHAMBER WITH E-BEAM | KOC | 1995-01-19 | 419 |
Recalls
openFDA lists no recalls under a recalling firm named In-Line Diagnostics Corp..
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 In-Line Diagnostics Corp.?
FDA lists 8 510(k) clearances under the applicant name “In-Line Diagnostics Corp.” (first 1995, latest 2000), across 4 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 In-Line Diagnostics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name In-Line Diagnostics Corp. is 177 days.
Which FDA product codes appear under In-Line Diagnostics Corp.?
The most frequent FDA product codes under this applicant name are MQS (System, Hemodialysis, Access Recirculation Monitoring, 5); GKF (Instrument, Hematocrit, Automated, 1); JPI (Device, Hematocrit Measuring, 1).
Next steps
- See all 8 In-Line Diagnostics Corp. clearances with predicates and recalls
- Run predicate analysis for product code MQS, In-Line Diagnostics Corp.'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.