# K990177: Nellcor Puritan Bennett Achieva Ventilator and Report Generator

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Nov 18, 1999 after 303 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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 K894316 (1989). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903010: Continuous Volume Ventilator Model LP10, Aequitron Medical, Inc. (1990) Summary page 1.
- K894316: Amadeus Ventilator, Hamilton Medical, Inc. (1989) Summary page 1.

## Most influential descendants
- K034032: PLV Continuum Ventilator, Model P2000 (2004), 1 descendant of its own
- K081845: IVENT101 (2009), 0 descendants of its own
- K040712: Air Safety Hepa, Model 3500 (2004), 0 descendants of its own

## Indications for use
The Achieva Ventilator is intended to provide ventilatory support for pediatric {Patients should weigh no less than 11 Ibs. (5 kg)} and adult patients who require positive pressure mechanical ventilation. The ventilator is for use in home, institutional, and portable settings. The Achieva is contraindicated for use with anesthetic gases. This device is intended to be used on the order, and under the supervision, of a physician. The Achieva Report Generator is a management and information tool, to aid in the care of patients requiring ventilatory support. The information displayed by the Report Generator software is intended to be used by healthcare professionals to supplement data obtained using established clinical procedures. The Achieva Report Generator allows users to download, view, and print ventilator performance data that have been stored in the ventilator’s internal memory. Achieva Report Generator users can also capture and display a snapshot of real-time waveform data (pressure, peak flow, and volume).

Source page: https://510kreport.com/device/K990177
Methodology: https://510kreport.com/methodology