# K993666: Disetronic Pen P100

- Pathway: 510(k) (Special)
- Applicant: Disetronic Medical Systems
- Decided: Nov 22, 1999 after 21 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K905693 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982966: Disetronic Pen, Disetronic Medical Systems (1998) Summary page 1.
- K980755: B-D E ML Pen, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K981797: B-D Pen Ultra, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K982842: Humapen and Humapen Ergo, Eli Lilly and Co. (1998) Summary page 1.
- K983974: Owen Mumford 3ML Autopen, Owen Mumford USA, Inc. (1998) Summary page 1.

## Indications for use
The Disetronic Pen P100 is indicated for the injection of insulin inta the body

Source page: https://510kreport.com/device/K993666
Methodology: https://510kreport.com/methodology