# K951764: Unidos Universal Dosimeter Model 10002-with TNC Connector, 10005-with BNT Connector

- Pathway: 510(k) (Traditional)
- Applicant: Ptw-New York Corp.
- Decided: Oct 7, 1995 after 173 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K961208: 0.6CC Ionization Chamber - Waterproof 0.6CC Ionization Chamber (1996), 0 descendants of its own

## Recalls of this device
- May 27, 2015 · Class II · Z-2439-2015: In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visi

Source page: https://510kreport.com/device/K951764
Methodology: https://510kreport.com/methodology