# K963391: Speculite

- Pathway: 510(k) (Traditional)
- Applicant: Trylon Corp.
- Decided: Dec 12, 1997 after 471 days
- Product code: MPU (Source, Chemiluminescent Light)
- 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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 7, 2003 · Not classified · Z-0977-03: Lights split, spilling contents when bent to activate.

## Indications for use
Speculoscopy is indicated for use in those women who are currently recommended for cervical screening with pelvic examination and Pap smear. Speculoscopy is only to be used as an adjunct to the Pap smear, and only the combination of the two tests affords the clinician improved sensitivity in identifying women with mucosal abnormalities visualized on colposcopy. The combined results of the Pap smear with Speculoscopy in the screening examination, designated Pap Plus Speculoscopy, can allow for the identification of more women who are appropriate referrals for colposcopy or close follow up than Pap smear alone.

Source page: https://510kreport.com/device/K963391
Methodology: https://510kreport.com/methodology