Armstrong Ind., Inc.: FDA clearances and approvals
Armstrong Ind., Inc. has 5 FDA 510(k) clearances (first 1982, latest 1985), across 3 product codes in 2 review panels. Median 510(k) review time: 133 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 3 | 3 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| CCW | Laryngoscope, Rigid | 1 | 1 |
Review panels
- Cardiovascular (3)
- Anesthesiology (2)
Most recent Armstrong Ind., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852282 | SCHILLER MINISCOPE MS-2 EKG SCOPE | DPS | 1985-10-09 | 133 |
| K852281 | SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER | DPS | 1985-10-09 | 133 |
| K852181 | ELECTROCARDIOGRAPH | DPS | 1985-10-09 | 142 |
| K851705 | LARYNGOSCOPE | CCW | 1985-05-21 | 26 |
| K822727 | RESCUER | CAE | 1982-09-28 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Armstrong Ind., 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 Armstrong Ind., Inc. have?
Armstrong Ind., Inc. has 5 FDA 510(k) clearances (first 1982, latest 1985), across 3 product codes in 2 review panels.
How long does FDA take to clear Armstrong Ind., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Armstrong Ind., Inc.'s cleared 510(k)s is 133 days.
What devices does Armstrong Ind., Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 3); CAE (Airway, Oropharyngeal, Anesthesiology, 1); CCW (Laryngoscope, Rigid, 1).
Has Armstrong Ind., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Armstrong Ind., Inc. Related entities may recall under other names.
Next steps
- See all 5 Armstrong Ind., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Armstrong Ind., 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.