Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Functional Diagnostics A/S — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
329 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K014269 | POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL | Medtronic Functional Diagnostics A/S | 2002-11-21 | 329 | 0 |
| K011471 | BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE | Medtronic Functional Diagnostics A/S | 2002-11-08 | 543 | 0 |
| K002992 | DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013 | Medtronic Functional Diagnostics A/S | 2001-08-15 | 324 | 0 |
| K011472 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM | Medtronic Functional Diagnostics A/S | 2001-08-10 | 88 | 0 |
| K010130 | POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL | Medtronic Functional Diagnostics A/S | 2001-02-07 | 22 | 0 |
| K000386 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 90 | Medtronic Functional Diagnostics A/S | 2000-05-05 | 88 | 0 |
| K992715 | NEURO URODYNAMIC SUITE, MODEL 9032E0101 | Medtronic Functional Diagnostics A/S | 2000-02-28 | 200 | 0 |
| K992713 | POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLI | Medtronic Functional Diagnostics A/S | 1999-11-10 | 90 | 0 |
| K991389 | ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 | Medtronic Functional Diagnostics A/S | 1999-07-15 | 85 | 0 |
| K990375 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 3 | Medtronic Functional Diagnostics A/S | 1999-03-09 | 29 | 0 |
| K981733 | DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTEN | Medtronic Functional Diagnostics A/S | 1999-02-04 | 262 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda