# K062155: Digital MXR-D Flowmeter

- Pathway: 510(k) (Traditional)
- Applicant: Porter Instrument Co., Inc.
- Decided: Nov 9, 2006 after 104 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945722 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923781: MXR-2000 Flowmeter, Porter Instrument Co., Inc. (1993) Summary page 1.
- K052335: Analgesia Gas Machine, Model Digital Ultra, Accutron, Inc. (2005) Summary page 1.
- K945722: Matrx MDM, RA, Matrx Medical, Inc. (1994) Summary page 1.

## Recalls of this device
- Aug 26, 2008 · Not classified · Z-0228-2009: inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas

## Indications for use
The Digital MXR-D Flowmeter is intended for use in nitrous oxide/oxygen sedation systems for the delivery of a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.

Source page: https://510kreport.com/device/K062155
Methodology: https://510kreport.com/methodology