# K963903: Biospectrometer-NB Oximeter Iiii

- Pathway: 510(k) (Traditional)
- Applicant: Hutchinson Technology, Inc.
- Decided: Jan 27, 1998 after 484 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
100 later devices descend from it; 2 cite it directly.
0 of 101 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 no predicate by number.

## Most influential descendants
- K012759: Inspectra Tissue Spectrometer System (Inspectra), Model 325 (2002), 99 descendants of its own
- K023938: Modification to Inspectra Tissue Spectrometer System, Model 325 (2002), 98 descendants of its own
- K042020: Spectra Tissue Spectrometer System (Inspectra) (2004), 76 descendants of its own
- K053618: Inspectra Tissue Spectrometer System, Model 325 (2006), 75 descendants of its own
- K040684: T-Stat Microvascular Tissue Oximeter, Model 303 (2004), 67 descendants of its own

## Indications for use
The Biospectrometer — NB 1111 is intended to noninvasively and continuously measure hemoglobin oxygen saturation: - in the ear lobe with the 3mm probe - in the arm, leg, or shoulder with the 15mm probe. The value of these measurements in disease states has not been demonstrated.

Source page: https://510kreport.com/device/K963903
Methodology: https://510kreport.com/methodology