Alternative Design Systems, Inc.: FDA clearances and approvals
Alternative Design Systems, Inc. has 6 FDA 510(k) clearances (first 1983, latest 1988), across 6 product codes in 4 review panels. Median 510(k) review time: 93 days.
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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| FLS | Monitor, Apnea, Facility Use | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| JOS | Electrode, Electrosurgical | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Review panels
- Anesthesiology (2)
- Cardiovascular (2)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Alternative Design Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874719 | STRATUM ESU | JOS | 1988-02-16 | 91 |
| K874697 | STRATUM D | LDD | 1987-12-15 | 26 |
| K854757 | 5000 SERIES ECG ELECTRODES | DRX | 1986-04-23 | 147 |
| K853633 | TENS CONDUCTIVE MEDIA PAD | GXY | 1985-12-03 | 95 |
| K852515 | ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR | BZQ | 1985-06-24 | 11 |
| K830778 | MONITORING KIT AMK-1 | FLS | 1983-10-14 | 217 |
Recalls
openFDA lists no recalls under a recalling firm named Alternative Design Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Alternative Design Systems, Inc. have?
Alternative Design Systems, Inc. has 6 FDA 510(k) clearances (first 1983, latest 1988), across 6 product codes in 4 review panels.
How long does FDA take to clear Alternative Design Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Alternative Design Systems, Inc.'s cleared 510(k)s is 93 days.
What devices does Alternative Design Systems, Inc. make?
Its most frequent FDA product codes are BZQ (Monitor, Breathing Frequency, 1); DRX (Electrode, Electrocardiograph, 1); FLS (Monitor, Apnea, Facility Use, 1).
Has Alternative Design Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Alternative Design Systems, Inc. Related entities may recall under other names.
Next steps
- See all 6 Alternative Design Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZQ, Alternative Design Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.