Danninger Medical Technology, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Danninger Medical Technology, Inc.” (first 1984, latest 1994), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 107 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | 3 | 3 |
| HWJ | Awl | 1 | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
| JFA | Exerciser, Finger, Powered | 1 | 1 |
Review panels
- Physical Medicine (5)
- Orthopedic (1)
Most recent Danninger Medical Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931128 | BASIC SHOULDER CPM | BXB | 1994-05-06 | 427 |
| K933394 | DANNIFLEX CPM 600 | BXB | 1994-03-11 | 242 |
| K913026 | TTU-100THERMAL THERAPY UNIT | ILO | 1991-12-13 | 157 |
| K875223 | DANNINGER ORTHOPAEDIC AWL | HWJ | 1988-02-17 | 57 |
| K862730 | DANNIFLEX 400SL | BXB | 1986-07-24 | 6 |
| K844033 | MOBILIMB HAND UNIT | JFA | 1984-11-27 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Danninger Medical Technology, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Danninger Medical Technology, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Danninger Medical Technology, Inc.” (first 1984, latest 1994), 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 Danninger Medical Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Danninger Medical Technology, Inc. is 107 days.
Which FDA product codes appear under Danninger Medical Technology, Inc.?
The most frequent FDA product codes under this applicant name are BXB (Exerciser, Powered, 3); HWJ (Awl, 1); ILO (Pack, Hot Or Cold, Water Circulating, 1).
Next steps
- See all 6 Danninger Medical Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BXB, Danninger Medical Technology, 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.