510(k) · Cleared
ClearedVentilator with Respiratory Mechanics, Model 840
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · CBK Ventilator, Continuous, Facility Use
Cleared on Feb 15, 2007 as substantially equivalent to K970460 (Puritan Bennett Corp., 1998) and 4 other predicates after a 69-day review. Its family tree reaches back 4 generations to 1991. 1 of the 20 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 15, 2007
- Review
- 69 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K902859 (1991). 19 ancestors in all, the oldest K833982 (1984). No later device cites it as a predicate yet. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 3 generations backK961687 EVITA 4Drager, Inc. · 1996
- 2 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 1 generation backK984379 Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp. · 1998 · Recalled
- This deviceK063650 Ventilator with Respiratory Mechanics, Model 840Puritan Bennett Corp. · 2007
Class I recalls in this family
- K970460 Nellcor Puritan Bennett, 840 Ventilator System…direct predicate · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −3 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −2 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −1 | K984379 | Nellcor Puritan Bennett, 760 Ventilator System | Puritan Bennett Corp. | 1998 | 4 |
| 0 (this device) | K063650 | Ventilator with Respiratory Mechanics, Model 840 | Puritan Bennett Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 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? (5)
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 |
|---|---|---|---|
| * | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Summary page 1…lass II; Continuous Ventilator per 21 CFR §868.5895 Legally Marketed · Puritan-Bennett Corp. 840 Ventilator System, (Unmodified) Device: K970460 * Puritan-Bennett Corp. 840 Ventilator System with Bilevel… | 1998 |
| * | K984379 | Nellcor Puritan Bennett, 760 Ventilator SystemSummary page 1…* Puritan-Bennett Corp. 840 Ventilator System, K970460 * Puritan Bennett 760 Ventilator, K984379 * Puritan Bennett 7200 Ventilator, K930017 * Infrasonics Adul… | 1998 |
| * | K930017 | PB 7200 Series Ventilatory System W/KeyboardSummary page 1…K970460 * Puritan Bennett 760 Ventilator, K984379 * Puritan Bennett 7200 Ventilator, K930017 * Infrasonics Adult Star Ventilator, K922654 * Viasys Avea Ve… | 1994 |
| * | K922654 | Ventilator Adult Star ModificationSummary page 1…0 Ventilator, K984379 * Puritan Bennett 7200 Ventilator, K930017 * Infrasonics Adult Star Ventilator, K922654 * Viasys Avea Ventilator, K062093 DEVICE DESCRIPTION The Respiratory Mechanics Option enable… | 1992 |
| * | K062093 | Avea VentilatorSummary page 1…nnett 7200 Ventilator, K930017 * Infrasonics Adult Star Ventilator, K922654 * Viasys Avea Ventilator, K062093 DEVICE DESCRIPTION The Respiratory Mechanics Option enables the 840 Ventilator System to implement three new respiratory maneu… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 6 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
- 6 other devices also cite its predicate K970460.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 840 Ventilator with Respiratory Mechanics Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions. The 840 Ventilator with Respiratory Mechanics Options is intended for a wide range of patients ranging from neonate to adult (VT 5-2500 mL with…
Read the full statement (121 words)
The 840 Ventilator with Respiratory Mechanics Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions.
The 840 Ventilator with Respiratory Mechanics Options is intended for a wide range of patients ranging from neonate to adult (VT 5-2500 mL with NeoMode) or from infant to adult (VT 2 5 -2 50 0 mnL)
The 840 Ventilator with Respiratory Mechanics is intended for use in hospital and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063650: Ventilator with Respiratory Mechanics, Model 840.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063650
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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