510(k) · Cleared
ClearedPolygram Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synectics Medical, Inc. · BZG Spirometer, Diagnostic
Cleared on Jul 7, 1995 after a 191-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jul 7, 1995
- Review
- 191 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK946322 Polygram SoftwareSynectics Medical, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK981733 Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension…Medtronic Functional Diagnostics A/S · 1999 · Recalled
- Descendant · 2 generations on · 0 of its ownK011471 Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile)…Medtronic Functional Diagnostics A/S · 2002
- Descendant · cites it directly · 0 of its ownK992713 Polygraf ID, Polygram '98 Esophageal Manometry Testing Application…Medtronic Functional Diagnostics A/S · 1999
Most influential descendants
Showing 3 of 3 · See all- K981733Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111Medtronic Functional Diagnostics A/S · 1999 · cites it directly1descendant
- K011471Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberMedtronic Functional Diagnostics A/S · 2002 · 2 generations on0descendants
- K992713Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models…Medtronic Functional Diagnostics A/S · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946322 | Polygram Software | Synectics Medical, Inc. | 1995 | — |
| +1 | K981733 | Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111 | Medtronic Functional Diagnostics A/S | 1999 | 1 |
| +2 | K011471 | Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber… | Medtronic Functional Diagnostics A/S | 2002 | — |
| +1 | K992713 | Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models… | Medtronic Functional Diagnostics A/S | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 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, K981733 (Medtronic Functional Diagnostics A/S, 1999) has gone furthest, with 1 descendant 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/K946322 · printed Nov 4, 2026
Cite this page
510(k) Report. “K946322: Polygram Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K946322
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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