# K060751: Inovo, Inc. Accupulse Single Lumen Conserving Regulator

- Pathway: 510(k) (Traditional)
- Applicant: Inovo, Inc.
- Decided: Jul 18, 2006 after 119 days
- Product code: NFB (Conserver, Oxygen)
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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: 3 generations back to K963247 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032018: Easy Pulse II Oxygen Conserver, Precision Medical, Inc. (2003) Summary page 1.
- K020475: Chad Therapeutics Oxypenumatic Cypress Model 511, Chad Therapeutics, Inc. (2002) Summary page 1.
- K031983: Inovo, Inc, Economizer Conserving Regulator, Inovo, Inc. (2003) Summary page 1.

## Recalls of this device
- Apr 26, 2019 · Class II · Z-2099-2019: The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.

## Indications for use
The Inovo AccuPulse Single Lumen Pneumatic Conserving Regulator is used to deliver a prescribed flow of medical-grade oxygen to the patient while conserving gas from a high-pressure oxygen cylinder, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

Source page: https://510kreport.com/device/K060751
Methodology: https://510kreport.com/methodology