510(k) · Cleared
ClearedNDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model 2001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ndd Medical Technologies · BZG Spirometer, Diagnostic
Cleared on May 23, 2000 as substantially equivalent to K944762 (Puritan Bennett Corp., 1994) after a 187-day review. Its family tree reaches back 1 generation to 1994. 10 later devices descend from it.
- Decided
- May 23, 2000
- Review
- 187 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944762 (1994). 10 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK944762 Puritan-Bennett Renaissance Spirometry Systemwith the…Puritan Bennett Corp. · 1994
- This deviceK993921 NDD Medical Technologies Easyone Spirometer: Frontline Model 2000…Ndd Medical Technologies · 2000
- Descendant · cites it directly · 4 of its ownK123896 CCS-200 SpirometerBenson Medical Instruments Co. · 2013
- Descendant · 2 generations on · 3 of its ownK130322 SPM-300Bionet Co., Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK220535 Cardio10Bionet Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK161536 EasyOne Air SpirometerNdd Medizintechnik AG · 2017
- Descendant · cites it directly · 1 of its ownK092813 Astrasonic Spirometer, Model 29-8000Sdi Diagnostics, Inc. · 2010
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K123896CCS-200 SpirometerBenson Medical Instruments Co. · 2013 · cites it directly4descendants
- K130322SPM-300Bionet Co., Ltd. · 2013 · 2 generations on3descendants
- K220535Cardio10Bionet Co., Ltd. · 2022 · 3 generations on2descendants
- K161536EasyOne Air SpirometerNdd Medizintechnik AG · 2017 · cites it directly1descendant
- K092813Astrasonic Spirometer, Model 29-8000Sdi Diagnostics, Inc. · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB… | Puritan Bennett Corp. | 1994 | — |
| 0 (this device) | K993921 | NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and… | Ndd Medical Technologies | 2000 | — |
| +1 | K123896 | CCS-200 Spirometer | Benson Medical Instruments Co. | 2013 | — |
| +2 | K130322 | SPM-300 | Bionet Co., Ltd. | 2013 | — |
| +3 | K220535 | Cardio10 | Bionet Co., Ltd. | 2022 | — |
| +1 | K161536 | EasyOne Air Spirometer | Ndd Medizintechnik AG | 2017 | — |
| +1 | K092813 | Astrasonic Spirometer, Model 29-8000 | Sdi Diagnostics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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 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? (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 |
|---|---|---|---|
| * | K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB Data… Our OCR of the scanned summary read K944672, FDA’s number for Insurg Laptie Needle Driver Suturing Devices (Boston Scientific Corp). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Puritan-Bennett Renaissance Spirometer”. | 1994 |
What descends from it? (10)
4 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?
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 | — |
What is it indicated for?
The ndd Medical Technologies EasyOne™ Spirometer is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.
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/K993921 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993921: NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model 2001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993921
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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