Andover Medical, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Andover Medical, Inc.” (first 1976, latest 1991), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 43 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 8 | 8 |
| GXY | Electrode, Cutaneous | 3 | 3 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 2 | 2 |
| DYG | Catheter, Flow Directed | 2 | 2 |
| KRB | Probe, Thermodilution | 2 | 2 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (16)
- Neurology (3)
- Anesthesiology (1)
Most recent Andover Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905729 | CANMED 451 | DRX | 1991-02-07 | 45 |
| K903427 | NORTECH MODEL 86901000 ELECTRODE | GXY | 1990-08-17 | 17 |
| K885171 | MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE | DRO | 1989-01-12 | 30 |
| K860636 | FASTRACE III, ECG ELECTRODE | DPS | 1986-05-09 | 77 |
| K854433 | ECG MONITORING/DEFIBRILLATION ELECTRODE | DRX | 1986-05-08 | 184 |
| K860535 | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) | CAT | 1986-04-01 | 48 |
| K860283 | AMI CARDIO-PAD | DRO | 1986-03-31 | 62 |
| K843412 | FLOW DIRECTED THERMODILUTION CATH W/VEN | KRB | 1984-11-20 | 81 |
| K843410 | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | KRB | 1984-11-20 | 81 |
| K843411 | THERMAL DILUTION CATHETER | DYG | 1984-10-18 | 48 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 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.
- Andover Coated Products, Inc. (2 510(k)s)
- Andover Healthcare, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Andover Medical, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Andover Medical, Inc.” (first 1976, latest 1991), across 9 product codes in 3 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 Andover Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Andover Medical, Inc. is 43 days.
Which FDA product codes appear under Andover Medical, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 8); GXY (Electrode, Cutaneous, 3); DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 2).
Next steps
- See all 21 Andover Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, 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.