NDC · Calculator, Drug Dose

Anesthesiology · 21 CFR 868.1890 · Class 2

Overview

Product CodeNDC
Device NameCalculator, Drug Dose
Regulation21 CFR 868.1890
Device ClassClass 2
Review PanelAnesthesiology

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.

RecordDevice NameApplicantDecision DateDecision
K253512MiniMed Go AppMedtronic MinimedJan 8, 2026SESE
K253281UpDocUpdoc, Inc.Dec 23, 2025SESE
K252104T1D1Comerge AGAug 20, 2025SESE
K241088EndoTool IV (3.1)Monarch Medical TechnologiesDec 11, 2024SESE
K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic MinimedNov 12, 2024SESE
K242066iSage RxAmalgam Rx, Inc.Aug 21, 2024SESE
K232451Insulia Bolus CompanionVoluntis Sa.Dec 12, 2023SESE
K230813BlueStar and BlueStar RxWelldoc, Inc.Jul 28, 2023SESE
K221924Digital RoutinesGnc Holdings, LLCMar 15, 2023SESE
K211160EndoTool SubQ 2.1Monarch Medical Technologies, LLCOct 28, 2021SESE
K203434BlueStar RxWelldoc, Inc.Sep 8, 2021SESE
K202596Insulia Diabetes Management CompanionVoluntis Sa.Jun 4, 2021SESE
K201619EndoTool IV SystemMonarch Medical Technologies, LLCAug 7, 2020SESE
K201337InPen SystemCompanion Medical, Inc.Jun 18, 2020SESE
K200443EndoTool IV 1.10Monarch Medical Technologies, LLCMar 17, 2020SESE
K190487InPen Dose CalculatorCompanion Medical, Inc.Feb 18, 2020SESE
K192841InPen SystemCompanion Medical, Inc.Feb 10, 2020SESE
K181916d-Nav SystemHygieia, Inc.Feb 4, 2019SESE
K180366EndoTool SubQAl Pacheco and AssociatesSep 20, 2018SESE
K181327InPen Dose CalculatorCompanion Medical, Inc.Jul 6, 2018SESE

Top Applicants

Innolitics

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