Medtronic Functional Diagnostics A/S: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Medtronic Functional Diagnostics A/S” (first 1999, latest 2002), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | 7 | 7 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 2 | 2 |
| FEN | Device, Cystometric, Hydraulic | 1 | 1 |
| MYE | System, Electrogastrography (Egg) | 1 | 1 |
Review panels
Most recent Medtronic Functional Diagnostics A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K014269 | POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 | MYE | 2002-11-21 | 329 |
| K011471 | BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER | FFX | 2002-11-08 | 543 |
| K002992 | DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 | IKT | 2001-08-15 | 324 |
| K011472 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID | FFX | 2001-08-10 | 88 |
| K010130 | POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 | FFX | 2001-02-07 | 22 |
| K000386 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 | FFX | 2000-05-05 | 88 |
| K992715 | NEURO URODYNAMIC SUITE, MODEL 9032E0101 | FEN | 2000-02-28 | 200 |
| K992713 | POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 | FFX | 1999-11-10 | 90 |
| K991389 | ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 | FFX | 1999-07-15 | 85 |
| K990375 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 | IKT | 1999-03-09 | 29 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Functional Diagnostics A/S.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Navigation, Inc. (44 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Functional Diagnostics A/S?
FDA lists 11 510(k) clearances under the applicant name “Medtronic Functional Diagnostics A/S” (first 1999, latest 2002), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medtronic Functional Diagnostics A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Functional Diagnostics A/S is 90 days.
Which FDA product codes appear under Medtronic Functional Diagnostics A/S?
The most frequent FDA product codes under this applicant name are FFX (System, Gastrointestinal Motility (Electrical), 7); IKT (Electrode, Needle, Diagnostic Electromyograph, 2); FEN (Device, Cystometric, Hydraulic, 1).
Next steps
- See all 11 Medtronic Functional Diagnostics A/S clearances with predicates and recalls
- Run predicate analysis for product code FFX, Medtronic Functional Diagnostics A/S's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.