# K982995: Accutrax, Model EPF840

- Pathway: 510(k) (Traditional)
- Applicant: Korr Medical Technologies, Inc.
- Decided: Dec 4, 1998 after 99 days
- Product code: BZH (Meter, Peak Flow, Spirometry)
- Device class: 2
- Regulation: 21 CFR 868.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943678 (1995). 1 ancestor in all.
20 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943678: Electronic Flow Meter, Vitalograph, Inc. (1995) Summary page 1.

## Most influential descendants
- K031024: Microlife Electronic Peak Flow Monitor, Model PF-100 (2003), 10 descendants of its own
- K040723: Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1 (with Software) (2004), 9 descendants of its own
- K022276: Kokomate (2002), 8 descendants of its own
- K051572: Koko Legend (2005), 7 descendants of its own
- K100687: Vitalograph Hand Held Spirometer, Model 2120 (2010), 6 descendants of its own

## Indications for use
This AccuTrax EPF840 device is intended for monitoring PEF and FEV1 for patient home and work use. The EPF840 is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the EPF840 is used to watch lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advise is required to understand the meaning and importance of the measures reported by the AccuTrax 840, and how to decide on an appropriate treatment plan. This treatment plan will tell you what action to take when there are changes in your PEF/FEV1 numbers.

Source page: https://510kreport.com/device/K982995
Methodology: https://510kreport.com/methodology