510(k) · Cleared
ClearedNellcor Puritan Bennett Achieva Ventilator and Report Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Nov 18, 1999 as substantially equivalent to K903010 (Aequitron Medical, Inc., 1990) and 1 other predicate after a 303-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it.
- Decided
- Nov 18, 1999
- Review
- 303 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K894316 (1989). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK894316 Amadeus VentilatorHamilton Medical, Inc. · 1989
- This deviceK990177 Nellcor Puritan Bennett Achieva Ventilator and Report GeneratorNellcor Puritan Bennett, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK034032 PLV Continuum Ventilator, Model P2000Respironics California, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK081845 IVENT101Versamed Medical Systems, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK040712 Air Safety Hepa, Model 3500Air Safety, Ltd. · 2004
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894316 | Amadeus Ventilator | Hamilton Medical, Inc. | 1989 | — |
| 0 (this device) | K990177 | Nellcor Puritan Bennett Achieva Ventilator and Report Generator | Nellcor Puritan Bennett, Inc. | 1999 | — |
| +1 | K034032 | PLV Continuum Ventilator, Model P2000 | Respironics California, Inc. | 2004 | — |
| +2 | K081845 | IVENT101 | Versamed Medical Systems, Inc. | 2009 | — |
| +1 | K040712 | Air Safety Hepa, Model 3500 | Air Safety, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K903010 | Continuous Volume Ventilator Model LP10Summary page 1…, Classification Number 73 CBK) Predicate Devices: The Achieva Ventilator is substantially equivalent to both the Nellcor Puritan Bennett Model LP10 Volume Ventilator (K903010) and the Hamilton Medical Amadeus Ventilator (K894316). Device Description: The Achieva Ventilator is a piston driven device wh… | 1990 |
| * | K894316 | Amadeus VentilatorSummary page 1…he Achieva Ventilator is substantially equivalent to both the Nellcor Puritan Bennett Model LP10 Volume Ventilator (K903010) and the Hamilton Medical Amadeus Ventilator (K894316). Device Description: The Achieva Ventilator is a piston driven device which can deliver a wide range of volumes, inspiratory t… | 1989 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K034032 (Respironics California, Inc., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
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…
Read the full statement (154 words)
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990177 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990177: Nellcor Puritan Bennett Achieva Ventilator and Report Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990177
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026