510(k) · Cleared
Recalled · Class II · 2013Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb Nebulizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan-Bennett Ireland, Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Mar 15, 2000 as substantially equivalent to K902859 (Siemens Life Support Systems, 1991) and 1 other predicate after a 363-day review. Its family tree reaches back 1 generation to 1991. 1 of the 5 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 15, 2000
- Review
- 363 days
- Class
- Class II
- Product code
- CAF
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902859 (1991). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- This deviceK990897 Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb…Puritan-Bennett Ireland, Ltd. · 2000
- Descendant · cites it directly · 0 of its ownK041082 Newport Nebsonic N550 Ultrasonic NebulizerNewport Medical Instruments, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK020357 800 Series Easyneb NebulizerNellcor Puritan Bennett, Inc. · 2002 · Recalled (Class I)
Class I recalls in this family
- K020357 800 Series Easyneb Nebulizercites it directly · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| 0 (this device) | K990897 | Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb Nebulizer | Puritan-Bennett Ireland, Ltd. | 2000 | — |
| +1 | K041082 | Newport Nebsonic N550 Ultrasonic Nebulizer | Newport Medical Instruments, Inc. | 2004 | — |
| +1 | K020357 | 800 Series Easyneb Nebulizer | Nellcor Puritan Bennett, Inc. | 2002 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 2004 | 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.
1 device in this family has a Class I recall. 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 CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 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 |
|---|---|---|---|
| * | K902859 | Servo Ventilator 300Summary page 1…s II per 21 CFR 868.5895 Continuous Ventilator Puritan-Bennett Corp. is claiming substantial equivalence to the following two predicate medical devices: Siemens Servo K902859 Class II, Ventilator 300 Continuous Ventilator per 21 CFR 868.5895 Siemens Servo Ultra K960854 Class II, Nebulizer 345 Nebuliz… | 1991 |
| * | K960854 | Siemens Servo Ultra Nebulizer 345Summary page 1…ivalence to the following two predicate medical devices: Siemens Servo K902859 Class II, Ventilator 300 Continuous Ventilator per 21 CFR 868.5895 Siemens Servo Ultra K960854 Class II, Nebulizer 345 Nebulizer per 21 CFR 868.5630 A Device Description: The device is a low-cost, critical… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 25, 2013 | Class II | Z-0822-2014 | Labeling Change Control | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators… |
| Jan 25, 2013 | Class II | Z-0821-2014 | Labeling Change Control | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K020357800 Series Easyneb NebulizerNellcor Puritan Bennett, Inc. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, 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 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The 700 Series Ventilator System is used to provide continuous ventilation to patients requiring respiratory support.
This device is used for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions. It also has the capability to provide nebulization through use of an optional accessory, the EasyNeb Nebulizer.
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/K990897 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990897: Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990897
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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