# K233038: Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Mar 8, 2024 after 165 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K933143 (1994). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202892: Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s, Edan Instruments, Inc. (2021) Summary page 5.

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1144-2026: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

## Indications for use
The device is intended to be used for measuring, storing, and reviewing of, and to generate prompts for, multiple physiological parameters of adults and pediatrics (including neonates). The device is intended for use by trained healthcare professionals in hospital environments. Parameters include: NIBP, SpO2, PR (pulse rate), TEMP. The F3000 Quick Temp module is not intended for neonates. The device is not intended for MRI environments.

Source page: https://510kreport.com/device/K233038
Methodology: https://510kreport.com/methodology