510(k) · Cleared
ClearedPuritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB Data Managementsoftware
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · BZG Spirometer, Diagnostic
Cleared on Dec 13, 1994 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Dec 13, 1994
- Review
- 77 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 4 citing it directly.
- This deviceK944762 Puritan-Bennett Renaissance Spirometry Systemwith the…Puritan Bennett Corp. · 1994
- Descendant · cites it directly · 10 of its ownK993921 NDD Medical Technologies Easyone Spirometer: Frontline Model 2000…Ndd Medical Technologies · 2000
- Descendant · 2 generations on · 4 of its ownK123896 CCS-200 SpirometerBenson Medical Instruments Co. · 2013
- Descendant · 3 generations on · 3 of its ownK130322 SPM-300Bionet Co., Ltd. · 2013
- Descendant · 4 generations on · 2 of its ownK220535 Cardio10Bionet Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK022103 Puritan-Bennett 700 Renaissance II Spirometry SystemPuritan Bennett Corp. · 2002
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K993921NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model…Ndd Medical Technologies · 2000 · cites it directly10descendants
- K123896CCS-200 SpirometerBenson Medical Instruments Co. · 2013 · 2 generations on4descendants
- K130322SPM-300Bionet Co., Ltd. · 2013 · 3 generations on3descendants
- K220535Cardio10Bionet Co., Ltd. · 2022 · 4 generations on2descendants
- K022103Puritan-Bennett 700 Renaissance II Spirometry SystemPuritan Bennett Corp. · 2002 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB… | Puritan Bennett Corp. | 1994 | — |
| +1 | K993921 | NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and… | Ndd Medical Technologies | 2000 | — |
| +2 | K123896 | CCS-200 Spirometer | Benson Medical Instruments Co. | 2013 | — |
| +3 | K130322 | SPM-300 | Bionet Co., Ltd. | 2013 | — |
| +4 | K220535 | Cardio10 | Bionet Co., Ltd. | 2022 | — |
| +1 | K022103 | Puritan-Bennett 700 Renaissance II Spirometry System | Puritan Bennett Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZG? 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 BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 164 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?
- Of its descendants, K993921 (Ndd Medical Technologies, 2000) has gone furthest, with 10 descendants of its own.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, 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 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K944762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944762: Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB Data Managementsoftware.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944762
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026