# K101539: Vital Signs Monitor Model M3B

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Nov 24, 2010 after 174 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1152-2026: 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.

Source page: https://510kreport.com/device/K101539
Methodology: https://510kreport.com/methodology