# K070985: Aesculon CHF, Hypertension & Pacemaker Clinic

- Pathway: 510(k) (Traditional)
- Applicant: Osypka Medical, Inc.
- Decided: Feb 1, 2008 after 301 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000126 (2000). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011439: Modification to Bioz.Com Hemodynamic Monitor, Cardiodynamics International Corp. (2001) Summary page 1.
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V, Masimo Corp. (2004) Summary page 1.

## Most influential descendants
- K081035: Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2 (2008), 3 descendants of its own
- K150095: ReDs Wearable System (2015), 1 descendant of its own
- K180479: ReDS System (2019), 0 descendants of its own
- K082242: Icon, Model C3 (2008), 0 descendants of its own

## Indications for use
The AESCULON®, AESCULON® CHF Clinic TM, AESCULON® Hypertension ClinicTM and AESCULON® Pacemaker ClinicTM are intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K070985
Methodology: https://510kreport.com/methodology