# K142123: Reach Access Telemedicine Dose Calculator

- Pathway: 510(k) (Traditional)
- Applicant: Reach Health, Inc.
- Decided: Sep 24, 2014 after 51 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011571 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121542: Picis Weight Based Dose Converter, Picis, Inc. (2012) Summary page 4.

## Indications for use
The REACH Access Telemedicine Dose Calculator is designed for used by trained clinicians to calculate any individual patient's dose for a given agent based on a weight determined by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight-based dose. The REACH Access Telemedicine Dose Calculator is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program. The REACH Access Telemedicine Dose Calculator is intended to be used as an aid in the consultative process and does not overrule or replace physician judgment or diagnosis.

Source page: https://510kreport.com/device/K142123
Methodology: https://510kreport.com/methodology