510(k) · Cleared
ClearedSPM-300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionet Co., Ltd. · BZG Spirometer, Diagnostic
Cleared on Nov 15, 2013 as substantially equivalent to K971336 (Caird Technology, 1998) and 1 other predicate after a 280-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Nov 15, 2013
- Review
- 280 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K944762 (1994). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK944762 Puritan-Bennett Renaissance Spirometry Systemwith the…Puritan Bennett Corp. · 1994
- 2 generations backK993921 NDD Medical Technologies Easyone Spirometer: Frontline Model 2000…Ndd Medical Technologies · 2000
- 1 generation backK123896 CCS-200 SpirometerBenson Medical Instruments Co. · 2013
- This deviceK130322 SPM-300Bionet Co., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK220535 Cardio10Bionet Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK231160 Cardio Q50, Cardio Q70Bionet Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK231150 Cardio P1Bionet Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB… | Puritan Bennett Corp. | 1994 | — |
| −2 | K993921 | NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and… | Ndd Medical Technologies | 2000 | — |
| −1 | K123896 | CCS-200 Spirometer | Benson Medical Instruments Co. | 2013 | — |
| 0 (this device) | K130322 | SPM-300 | Bionet Co., Ltd. | 2013 | — |
| +1 | K220535 | Cardio10 | Bionet Co., Ltd. | 2022 | — |
| +2 | K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023 | — |
| +2 | K231150 | Cardio P1 | Bionet Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K971336 | Caird Technology SpirometerSummary page 1…5 10O(k) Number K 130322 1.3 Identification of Legally Marketed Device Substantial equivalence is claimed to the Caird Technology Spirometer (K971 336)2'which is marketed as the Medikro spirometer. 1.4 Device Description SPM-300 is a pulmonary function monitor… | 1998 |
| * | K123896 | CCS-200 Spirometer Cleared while this submission was under review Summary page 2…SPM-300's Indications for Use derive from the spirometer most recently cleared by FDA, which is Benson Medical Instruments' CCS-200 Spirometer (K 123896). Table 1: Comparison of SPM-300 to Predicate Device Ezssential Characteristic… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220535 | Cardio10 | 2022 | 2 |
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K220535 (Bionet Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K971336.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 SPM-300 Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients in general practice, specialty physician, and hospital settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130322: SPM-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130322
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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