# K992529: Tissue Spectroscope

- Pathway: 510(k) (Traditional)
- Applicant: Vital Medical, Ltd.
- Decided: Nov 17, 2000 after 478 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Laserflow BPM?Z: named in the summary without a submission number
- (no number) INVOS 3100A Cerebral Oximeter: named in the summary without a submission number
- (no number) LKB-Wallac 1230 Arcus Fluorometer: named in the summary without a submission number

## Most influential descendants
- K051145: Critiview (2006), 1 descendant of its own
- K062977: Critiview, Model CRV3 (2007), 0 descendants of its own

## Indications for use
The Tissue Spectroscope is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in these parameters provide information on tissue metabolic activity.

Source page: https://510kreport.com/device/K992529
Methodology: https://510kreport.com/methodology