Data / Medical devices / Calculator, Drug Dose
Calculator, Drug Dose (NDC): 28 FDA-registered makers in 9 countries
28 establishments in 9 countries are registered with the FDA to make Calculator, Drug Dose (product code NDC, Class 2, 21 CFR 868.1890). 12 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 56 510(k) clearances under this code, the latest on October 5, 2026, and lists 14 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NDC
- Device class
- 2
- Regulation
- 868.1890
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 20 |
| France | 1 |
| Switzerland | 1 |
| Spain | 1 |
| Poland | 1 |
| Israel | 1 |
| Mexico | 1 |
| China | 1 |
| Taiwan | 1 |
Makers of Calculator, Drug Dose
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 6 | January 8, 2026 | 0 | 4 | 0 | api.fda.gov |
| Glytec, LLC | Greenville, SC, United States | Manufacturer | 4 | May 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Monarch Medical Technologies | Charlotte, NC, United States | Complaint file establishment, Manufacturer | 4 | December 11, 2024 | 0 | 2 | 0 | api.fda.gov |
| Voluntis | Rueil-Malmaison Hauts-de-Seine, France | Manufacturer | 3 | November 7, 2017 | 0 | 1 | 0 | api.fda.gov |
| Amalgam Rx, Inc | Wilmington, DE, United States | Manufacturer | 2 | August 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Welldoc | Columbia, MD, United States | Manufacturer | 2 | July 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Comerge AG | Zurich, Switzerland | Manufacturer | 1 | August 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medical Decision Network | Charlottesville, VA, United States | Manufacturer | 1 | September 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| Pronia Medical Systems | Lewisburg, PA, United States | Manufacturer | 1 | August 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| Picis Clinical Solutions, Inc. | Peabody, MA, United States | Complaint file establishment, Manufacturer | 1 | August 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Picis Clinical Solutions, S.A.U. | Barcelona, Spain | Manufacturer | 1 | August 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Updoc | Mountain View, CA, United States | Manufacturer, Specification developer | 1 | December 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Biointellisense Inc. | Redwood City, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinico Medical Sp. z o.o. | Blonie/Miekinia Dolnoslaskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deka Research & Development Corp. | Manchester, NH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreamed Diabetes Ltd | Petah Tikva Tel Aviv, Israel | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insulet Corporation | Acton, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merrimack Manufacturing | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merrimack Manufacturing | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NPA de Mexico S.de R.L. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diabetes Care, Inc. | Indianapolis, IN, United States | Manufacturer | 0 | 0 | 6 | 0 | api.fda.gov | |
| Sanmina | Kunshan Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wistron Medical Technology Corporation | Zhubei City Hsinchu(County), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.