Witt Biomedical Corporation: FDA clearances and approvals
Witt Biomedical Corporation has 11 FDA 510(k) clearances (first 1988, latest 2010), across 4 product codes in 2 review panels. Median 510(k) review time: 146 days. openFDA lists 1 product recall by a recalling firm named Witt Biomedical Corporation.
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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 3 | 3 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
Review panels
- Cardiovascular (8)
- Radiology (3)
Most recent Witt Biomedical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101571 | XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS | MWI | 2010-10-26 | 144 |
| K063840 | XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION | MWI | 2007-02-06 | 42 |
| K063547 | CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM | MWI | 2006-12-21 | 27 |
| K040195 | CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM | LLZ | 2004-04-07 | 70 |
| K033030 | CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM | MWI | 2004-02-24 | 151 |
| K010058 | IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK | LLZ | 2001-03-21 | 72 |
| K973474 | WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS | MHX | 1998-03-13 | 182 |
| K950436 | WITT BIOMEDICAL SERIES IV | MHX | 1995-11-02 | 273 |
| K945582 | WITT BIOMEDICAL IMAGE III | LLZ | 1995-06-19 | 217 |
| K923054 | WITT BIOMEDICAL SERIES II-EP | MHX | 1993-02-25 | 246 |
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: 2005-09-16.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Witt Biomedical Corporation have?
Witt Biomedical Corporation has 11 FDA 510(k) clearances (first 1988, latest 2010), across 4 product codes in 2 review panels.
How long does FDA take to clear Witt Biomedical Corporation's 510(k)s?
The median time from FDA receipt to decision across Witt Biomedical Corporation's cleared 510(k)s is 146 days.
What devices does Witt Biomedical Corporation make?
Its most frequent FDA product codes are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 4); LLZ (System, Image Processing, Radiological, 3); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 3).
Has Witt Biomedical Corporation had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Witt Biomedical Corporation; the most recent began 2005-09-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 11 Witt Biomedical Corporation clearances with predicates and recalls
- Run predicate analysis for product code MWI, Witt Biomedical Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.