# K982966: Disetronic Pen

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems
- Decided: Oct 19, 1998 after 55 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: 2 generations back to K905693 (1991). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942159: Novopen 1.5, Novo Nordisk Pharmaceuticals, Inc. (1995) Summary page 1.
- K954064: Becton Dickinson Syringse, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995). Our OCR of the scanned summary read K354064, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words.
- K973044: Disetronic H-Tron Plus V 100 Insulin Infusion Pump, Disetronic Medical Systems (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K941567: Diathermy Device-Microfocus, Cheung Laboratories, Inc. (1996). Our OCR of the scanned summary read K941567, FDA’s number for Diathermy Device-Microfocus (Cheung Laboratories, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “B-D Injection Pen”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K070100: Haselmeier Pen (2007), 2 descendants of its own
- K083457: Tactipen (2009), 0 descendants of its own
- K082616: Haselmeier Pen 8 (2008), 0 descendants of its own
- K993666: Disetronic Pen P100 (1999), 0 descendants of its own

## Indications for use
The device is indicated for the injection of insulin into the body.

Source page: https://510kreport.com/device/K982966
Methodology: https://510kreport.com/methodology