# K946322: Polygram Software

- Pathway: 510(k) (Traditional)
- Applicant: Synectics Medical, Inc.
- Decided: Jul 7, 1995 after 191 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K981733: Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111 (1999), 1 descendant of its own
- K011471: Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber Prober (2002), 0 descendants of its own
- K992713: Polygraf ID, Polygram '98 Esophageal Manometry Testing Application, Models 9043G0121-9043G0151, 9043S0101 (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K946322
Methodology: https://510kreport.com/methodology