# K082899: Dynamipeak Peak Flow Meter

- Pathway: 510(k) (Traditional)
- Applicant: Dynamitech Medical, Inc.
- Decided: Mar 10, 2009 after 161 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: 3 generations back to K926307 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030586: Micropeak, Micro Direct, Inc. (2003) Summary page 2.
- K963095: Trupeak Peak Flow Meter, Monaghan Medical Corp. (1996) Summary page 2.
- K955234: Trupeak Peak Flow Meter, Monaghan Medical Corp. (1996) Summary page 2.
- K781922: Pulmonary Monitor, Vitalograph, Ltd. (1979) Summary page 2.
- (no number) GALEMED Peak Flow Meter, Models 3754/3752: named in the summary without a submission number

## Indications for use
The DynamiPeak TM Peak Flow Meter is designed as a single-patient use device to measure the Peak Expiratory Flow Rate (PEFR). The device is intended for use by children to adults.

Source page: https://510kreport.com/device/K082899
Methodology: https://510kreport.com/methodology