# K101983: Critical Care Assessment

- Pathway: 510(k) (Traditional)
- Applicant: Critical Patient Care, Inc.
- Decided: Sep 21, 2010 after 69 days
- Product code: JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic)
- Device class: 2
- Regulation: 21 CFR 870.2780
- 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 K853124 (1985). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083735: Ansha Autonomic Nervous System Health Assessment Plus, Medtechs, LLC (2009) Summary page 1.

## Most influential descendants
- K191266: VitalScan ANS (2020), 0 descendants of its own

## Indications for use
'Critical Care Assessment' is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rate electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.

Source page: https://510kreport.com/device/K101983
Methodology: https://510kreport.com/methodology