510(k) · Cleared
ClearedNellcor Puritan Bennett Gemini
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 Sep 12, 1997 as substantially equivalent to K950484 (Bird Products Corp., 1996) after an 88-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 12, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950484 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK950484 Tbird VS Ventilator and Tbird Avs VentilatorBird Products Corp. · 1996
- This deviceK972248 Nellcor Puritan Bennett GeminiNellcor Puritan Bennett, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950484 | Tbird VS Ventilator and Tbird Avs Ventilator | Bird Products Corp. | 1996 | — |
| 0 (this device) | K972248 | Nellcor Puritan Bennett Gemini | Nellcor Puritan Bennett, Inc. | 1997 | — |
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? (1)
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 |
|---|---|---|---|
| * | K950484 | Tbird VS Ventilator and Tbird Avs VentilatorSummary page 3…M 5000 low/high inspiration pressure alarm (optional) 10. model 7820 oxygen monitor (optional) 19.8 Predicate Device Equivalence The model TBird VS Ventilation System (K950484) from Bird Products Corp. is the predicate device for the Nellcor Puritan Bennett Gemini Ventilator. Gemini offers a subset of th… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K950484.
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 Gemini Ventilator is intended to provide invasive or non-invasive pressure support ventilation to pediatric and adult patients requiring respiratory support. For invasive and non-invasive pressure ventilation, and non-invasive volume targeted ventilation, the patient should weigh no less than 44 pounds (20 kg). For invasive volume targeted ventilation, the patient should be at least 88 pounds (40 kg). Pediatric restrictions include those patients who…
Read the full statement (111 words)
The Gemini Ventilator is intended to provide invasive or non-invasive pressure support ventilation to pediatric and adult patients requiring respiratory support. For invasive and non-invasive pressure ventilation, and non-invasive volume targeted ventilation, the patient should weigh no less than 44 pounds (20 kg). For invasive volume targeted ventilation, the patient should be at least 88 pounds (40 kg). Pediatric restrictions include those patients who require invasive ventilation using an ET4 or smaller diameter tube. The Gemini can be used in hospital and hospital-like settings such as the ICU, sub-acute care and nursing home settings. This device is intended to be used on the order, and under the supervision, of a physician.
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/K972248 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972248: Nellcor Puritan Bennett Gemini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972248
Report an extraction error
Are you the manufacturer?
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