Dept. of the Army: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dept. of the Army” (first 1989, latest 2003), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 109 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 |
|---|---|---|---|
| MAC | Decontamination Kit | 2 | 2 |
| FLE | Sterilizer, Steam | 1 | 1 |
| FPP | Stretcher, Hand-Carried | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
Review panels
- General Hospital (4)
- Radiology (1)
Most recent Dept. of the Army 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023969 | REACTIVE SKIN DECONTAMINATION LOTION | MAC | 2003-03-25 | 116 |
| K934818 | HAND HELD DENTAL X-RAY DEVICE | IZL | 1994-01-24 | 109 |
| K921613 | STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510 | FLE | 1993-01-29 | 298 |
| K901760 | LITTER, FOLDING RIGID POLE, DECONTAMINABLE | FPP | 1990-07-10 | 83 |
| K894455 | DECONTAMINATING KIT, SKIN: M291 | MAC | 1989-08-15 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Dept. of the Army.
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.
- Dept. of the Navy (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dept. of the Army?
FDA lists 5 510(k) clearances under the applicant name “Dept. of the Army” (first 1989, latest 2003), 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 Dept. of the Army?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dept. of the Army is 109 days.
Which FDA product codes appear under Dept. of the Army?
The most frequent FDA product codes under this applicant name are MAC (Decontamination Kit, 2); FLE (Sterilizer, Steam, 1); FPP (Stretcher, Hand-Carried, 1).
Next steps
- See all 5 Dept. of the Army clearances with predicates and recalls
- Run predicate analysis for product code MAC, Dept. of the Army'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.