# K143103: PROPENCIL Smoke Pencil

- Pathway: 510(k) (Traditional)
- Applicant: Bio Protech, Inc.
- Decided: Jul 16, 2015 after 260 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K791137 (1979). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120454: Safeair Smoke Pencil,, Lna Medical Aps (2012) Summary page 4.
- K982309: Smoke Evacuation Attachment 130XXX TBD, Conmedcorp (1998) Summary page 4.
- K791137: Single Use Monopolar Hand Control Pencil, Davol, Inc. (1979) Summary page 4.

## Indications for use
PROPENCIL™ Smoke pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Source page: https://510kreport.com/device/K143103
Methodology: https://510kreport.com/methodology