# K974292: Nihon Kohden TL-101T, TL-120T and TL-121T SPO2 Probes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Jun 8, 1998 after 206 days
- Product code: DQA (Oximeter)
- 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
Longest line of descent: 1 generation back to K884536 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884536: AL-800PA Pulse Oximeter Module, Nihon Kohden America, Inc. (1989). Our OCR of the scanned summary read K884538, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Nihon Kohden TL-101S, TL-120S and TL-121S SpO2 Probes”. Summary page 1.

## Indications for use
The TL-101T, TL-120T and TL-121T SpO2 Probes are intended for use with Nihon Kohden patient monitoring devices to measure the blood oxygen saturation of a patient based upon the amount of reflected or scattered light. The TL-101T is a finger probe intended for use on adult patients heavier than 20 kg. The TL-120T is a multi-site probe intended for use on adults and infants heavier than 3 kg. The TL-121T is a foot probe intended for use on infants and neonates lighter than 3 kg.

Source page: https://510kreport.com/device/K974292
Methodology: https://510kreport.com/methodology