# K841909: Vaginal Speculum - Disposable

- Pathway: 510(k) (Traditional)
- Applicant: Galenica Enterprises, Inc.
- Decided: Jul 31, 1984 after 83 days
- Product code: HIB (Speculum, Vaginal, Nonmetal)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Apr 13, 2015 · Class II · Z-1824-2015: Small sized specula were incorrectly packaged in printed bags for the medium sized speculum

Source page: https://510kreport.com/device/K841909
Methodology: https://510kreport.com/methodology