# K081035: Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2

- Pathway: 510(k) (Special)
- Applicant: Osypka Medical, Inc.
- Decided: May 30, 2008 after 49 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: 4 generations back to K000126 (2000). 5 ancestors in all.
3 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)
- K070985: Aesculon CHF, Hypertension & Pacemaker Clinic, Osypka Medical, Inc. (2008). Our reading of the summary gave K070895, FDA’s number for Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F… (STERIS Corporation). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “AESCULON® Version C1.1”.

## Most influential descendants
- 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™ and AESCULON® Hypertension Clinic® and AESCULON® Pacemaker Clinic® 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/K081035
Methodology: https://510kreport.com/methodology