Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1890](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1890) → NDC — Calculator, Drug Dose

# NDC · Calculator, Drug Dose

_Anesthesiology · 21 CFR 868.1890 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/NDC

## Overview

- **Product Code:** NDC
- **Device Name:** Calculator, Drug Dose
- **Regulation:** [21 CFR 868.1890](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1890)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 55)

Showing 20 most recent of 55 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K254102](/device/K254102.md) | Glucommander | Glytec, LLC | May 27, 2026 | SESE |
| [K260910](/device/K260910.md) | EndoTool IV Cloud 1.0 | Glooko, Inc. | May 1, 2026 | SESE |
| [K253512](/device/K253512.md) | MiniMed Go App | Medtronic Minimed | Jan 8, 2026 | SESE |
| [K253281](/device/K253281.md) | UpDoc | Updoc, Inc. | Dec 23, 2025 | SESE |
| [K252104](/device/K252104.md) | T1D1 | Comerge AG | Aug 20, 2025 | SESE |
| [K241088](/device/K241088.md) | EndoTool IV (3.1) | Monarch Medical Technologies | Dec 11, 2024 | SESE |
| [K242775](/device/K242775.md) | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | Nov 12, 2024 | SESE |
| [K242066](/device/K242066.md) | iSage Rx | Amalgam Rx, Inc. | Aug 21, 2024 | SESE |
| [K232451](/device/K232451.md) | Insulia Bolus Companion | Voluntis Sa. | Dec 12, 2023 | SESE |
| [K230813](/device/K230813.md) | BlueStar and BlueStar Rx | Welldoc, Inc. | Jul 28, 2023 | SESE |
| [K221924](/device/K221924.md) | Digital Routines | Gnc Holdings, LLC | Mar 15, 2023 | SESE |
| [K211160](/device/K211160.md) | EndoTool SubQ 2.1 | Monarch Medical Technologies, LLC | Oct 28, 2021 | SESE |
| [K203434](/device/K203434.md) | BlueStar Rx | Welldoc, Inc. | Sep 8, 2021 | SESE |
| [K202596](/device/K202596.md) | Insulia Diabetes Management Companion | Voluntis Sa. | Jun 4, 2021 | SESE |
| [K201619](/device/K201619.md) | EndoTool IV System | Monarch Medical Technologies, LLC | Aug 7, 2020 | SESE |
| [K201337](/device/K201337.md) | InPen System | Companion Medical, Inc. | Jun 18, 2020 | SESE |
| [K200443](/device/K200443.md) | EndoTool IV 1.10 | Monarch Medical Technologies, LLC | Mar 17, 2020 | SESE |
| [K190487](/device/K190487.md) | InPen Dose Calculator | Companion Medical, Inc. | Feb 18, 2020 | SESE |
| [K192841](/device/K192841.md) | InPen System | Companion Medical, Inc. | Feb 10, 2020 | SESE |
| [K181916](/device/K181916.md) | d-Nav System | Hygieia, Inc. | Feb 4, 2019 | SESE |

## Top Applicants

- Voluntis Sa. — 5 clearances
- Companion Medical, Inc. — 4 clearances
- Glytec, LLC — 3 clearances
- Monarch Medical Technologies — 3 clearances
- Monarch Medical Technologies, LLC — 3 clearances

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**Source:** [https://fda.innolitics.com/productcode/NDC](https://fda.innolitics.com/productcode/NDC)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com