| Device Type ID | 2516 |
| Device Name | Calculator, Drug Dose |
| Regulation Description | Predictive Pulmonary-function Value Calculator. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.1890 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NDC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2516 |
| Device | Calculator, Drug Dose |
| Product Code | NDC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Predictive Pulmonary-function Value Calculator. |
| CFR Regulation Number | 868.1890 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALR TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELI LILLY AND CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELI LILLY AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLYTEC, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSULIN ALGORITHMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICAL DECISION NETWORK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MONARCH MEDICAL TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
REACH HEALTH , INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIABETES CARE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Software Programming Calculations | 33 |
Application Program Problem: Dose Calculation Error | 24 |
Computer Software Problem | 5 |
Patient Data Problem | 3 |
Data Problem | 3 |
Programming Issue | 2 |
Application Program Problem | 2 |
Device Issue | 1 |
Device Operational Issue | 1 |
Problem With Software Installation | 1 |
Application Program Problem: Parameter Calculation Error | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 77 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Roche Diabetes Care, Inc. | II | Feb-15-2018 |
| 2 | Roche Diabetes Care, Inc. | II | Dec-06-2017 |
| 3 | Roche Diabetes Care, Inc. | II | May-01-2017 |
| 4 | Roche Diabetes Care, Inc. | II | Jan-26-2017 |
| 5 | Roche Diabetes Care, Inc. | II | Nov-16-2016 |
| 6 | Voluntis | II | Nov-17-2018 |