# K121542: Picis Weight Based Dose Converter

- Pathway: 510(k) (Traditional)
- Applicant: Picis, Inc.
- Decided: Aug 27, 2012 after 95 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: 1 generation back to K011571 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011571: TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite, The RX Files Corp. (2001) Summary page 2.

## Most influential descendants
- K142123: Reach Access Telemedicine Dose Calculator (2014), 0 descendants of its own

## Indications for use
The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patients dose for a given agent based on a weight based dose determined by the clinician. Drug dosinb 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 Picis Weight Based Dose Converter is not a substitute for clinical reasoning. The Picis Weight Based Dose Converter 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.

Source page: https://510kreport.com/device/K121542
Methodology: https://510kreport.com/methodology