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/submissions/AN/subpart-b%E2%80%94diagnostic-devices/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 53) Showing 20 most recent of 53 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253512](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K253512.md) | MiniMed Go App | Medtronic Minimed | Jan 8, 2026 | SESE | | [K253281](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K253281.md) | UpDoc | Updoc, Inc. | Dec 23, 2025 | SESE | | [K252104](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K252104.md) | T1D1 | Comerge AG | Aug 20, 2025 | SESE | | [K241088](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K241088.md) | EndoTool IV (3.1) | Monarch Medical Technologies | Dec 11, 2024 | SESE | | [K242775](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K242775.md) | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | Medtronic Minimed | Nov 12, 2024 | SESE | | [K242066](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K242066.md) | iSage Rx | Amalgam Rx, Inc. | Aug 21, 2024 | SESE | | [K232451](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K232451.md) | Insulia Bolus Companion | Voluntis Sa. | Dec 12, 2023 | SESE | | [K230813](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K230813.md) | BlueStar and BlueStar Rx | Welldoc, Inc. | Jul 28, 2023 | SESE | | [K221924](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K221924.md) | Digital Routines | Gnc Holdings, LLC | Mar 15, 2023 | SESE | | [K211160](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K211160.md) | EndoTool SubQ 2.1 | Monarch Medical Technologies, LLC | Oct 28, 2021 | SESE | | [K203434](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K203434.md) | BlueStar Rx | Welldoc, Inc. | Sep 8, 2021 | SESE | | [K202596](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K202596.md) | Insulia Diabetes Management Companion | Voluntis Sa. | Jun 4, 2021 | SESE | | [K201619](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K201619.md) | EndoTool IV System | Monarch Medical Technologies, LLC | Aug 7, 2020 | SESE | | [K201337](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K201337.md) | InPen System | Companion Medical, Inc. | Jun 18, 2020 | SESE | | [K200443](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K200443.md) | EndoTool IV 1.10 | Monarch Medical Technologies, LLC | Mar 17, 2020 | SESE | | [K190487](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K190487.md) | InPen Dose Calculator | Companion Medical, Inc. | Feb 18, 2020 | SESE | | [K192841](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K192841.md) | InPen System | Companion Medical, Inc. | Feb 10, 2020 | SESE | | [K181916](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K181916.md) | d-Nav System | Hygieia, Inc. | Feb 4, 2019 | SESE | | [K180366](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K180366.md) | EndoTool SubQ | Al Pacheco and Associates | Sep 20, 2018 | SESE | | [K181327](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC/K181327.md) | InPen Dose Calculator | Companion Medical, Inc. | Jul 6, 2018 | SESE | ## Top Applicants - Voluntis Sa. — 5 clearances - Companion Medical, Inc. — 4 clearances - Monarch Medical Technologies, LLC — 3 clearances - Monarch Medical Technologies — 3 clearances - Welldoc, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/NDC](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/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