Medtronic Andover Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medtronic Andover Medical, Inc.” (first 1985, latest 1991), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 3 | 3 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Review panels
- Cardiovascular (5)
- Neurology (1)
Most recent Medtronic Andover Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910494 | RESTING EKG ELECTRODE SERIES | DRX | 1991-04-22 | 76 |
| K905446 | MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE | DRX | 1991-02-05 | 62 |
| K903018 | MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002 | LDD | 1990-12-03 | 145 |
| K903554 | NORTECH MODEL 87202204 ELECTRODE | GXY | 1990-08-30 | 23 |
| K882174 | MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE | DSA | 1988-07-22 | 65 |
| K852469 | SAF-D-FIB | DRX | 1985-09-16 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Andover Medical, Inc..
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 Andover Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Medtronic Andover Medical, Inc.” (first 1985, latest 1991), 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 Andover Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Andover Medical, Inc. is 70 days.
Which FDA product codes appear under Medtronic Andover Medical, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 3); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 1); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 6 Medtronic Andover Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Medtronic Andover Medical, Inc.'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.