FDA product code NDC: Calculator, Drug Dose
NDC is the FDA product code for calculator, drug dose. It is a Class II device, regulated under 21 CFR 868.1890 and reviewed by the Clinical Chemistry panel. FDA has cleared 55 510(k) submissions under NDC, 11 in the last five years, from 39 different applicants. The average 510(k) review took 158 days (median 126); 88 days on average over the last three years. FDA has posted 13 recalls for NDC devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Calculator, Drug Dose |
| Device class | Class II |
| Regulation | 21 CFR 868.1890 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for NDC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 258 |
| 2018 | 3 | 177 |
| 2019 | 1 | 202 |
| 2020 | 5 | 118 |
| 2021 | 3 | 250 |
| 2023 | 3 | 168 |
| 2024 | 3 | 111 |
| 2025 | 2 | 66 |
| 2026 | 3 | 88 |
Compare with all 510(k) review times · Search every NDC clearance
Top NDC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Voluntis Sa. | 5 | 2023-12-12 |
| Companion Medical, Inc. | 4 | 2020-06-18 |
| Glytec, LLC | 3 | 2026-05-27 |
| Monarch Medical Technologies | 3 | 2024-12-11 |
| Monarch Medical Technologies, LLC | 3 | 2021-10-28 |
34 more applicants have NDC clearances. See the full list in Caduvo.
Most recent NDC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254102 | Glytec, LLC | Glucommander | 2026-05-27 | 159 |
| K260910 | Glooko, Inc. | EndoTool IV Cloud 1.0 | 2026-05-01 | 43 |
| K253512 | Medtronic Minimed | MiniMed Go App | 2026-01-08 | 63 |
| K253281 | Updoc, Inc. | UpDoc | 2025-12-23 | 85 |
| K252104 | Comerge AG | T1D1 | 2025-08-20 | 48 |
Recalls for NDC devices
13 product recalls in 13 recall events; 4 initiated in the last five years and 5 still open. Most recent: 2026-06-16.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 3 |
| 2022 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code NDC?
NDC is the FDA product code for calculator, drug dose. It is a Class II device, regulated under 21 CFR 868.1890 and reviewed by the Clinical Chemistry panel.
What device class is NDC?
Class II, regulation 21 CFR 868.1890. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDC?
Across 55 cleared submissions the average was 158 days from receipt to decision (median 126).
Which companies have the most NDC clearances?
Voluntis Sa. (5); Companion Medical, Inc. (4); Glytec, LLC (3); Monarch Medical Technologies (3); Monarch Medical Technologies, LLC (3).
Have NDC devices been recalled?
Yes: 13 product recalls across 13 recall events; the most recent began 2026-06-16.
Next steps
- Run an FDA pathway report with predicate devices for product code NDC
- Run a recall and safety report across every NDC manufacturer
- Watch product code NDC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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