# K933611: The Bte WS30

- Pathway: 510(k) (Traditional)
- Applicant: Baltimore Therapeutic Equipment Co.
- Decided: Jun 20, 1994 after 336 days
- Product code: ISD (Exerciser, Measuring)
- Device class: 2
- Regulation: 21 CFR 890.5360
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Apr 9, 2015 · Class II · Z-1986-2015: On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar

Source page: https://510kreport.com/device/K933611
Methodology: https://510kreport.com/methodology