Ipos Luneburg: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Ipos Luneburg” (first 1980, latest 1984), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| IQI | Orthosis, Limb Brace | 1 | 1 |
| ITG | Bandage, Cast | 1 | 1 |
| ITO | Twister, Brace Setting | 1 | 1 |
| KFX | Assembly, Thigh/Knee/Shank/Ankle/Foot, External | 1 | 1 |
| KNP | Orthosis, Corrective Shoe | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Ipos Luneburg 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K834143 | NYLON COMPRESSION STUMP SHEATH | — | 1984-01-09 | 39 |
| K833868 | IPOS G.L.P. SYSTEM | KFX | 1983-11-28 | 21 |
| K831690 | IPOS ANTI-ADDUCTUS SHOE | KNP | 1983-06-24 | 31 |
| K802977 | IPOCARBON STRETCH STOCKINETTE | — | 1980-12-19 | 28 |
| K802976 | CARBONACRYL | — | 1980-12-19 | 28 |
| K800749 | IPOCON 7 | ITG | 1980-07-28 | 115 |
| K800716 | ORTHOTIC LEG GAIT CORRECTOR DEVICE | ITO | 1980-05-02 | 32 |
| K800715 | OHC DYNAMIC CLUB FOOT BRACE | IQI | 1980-05-02 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Ipos Luneburg.
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.
- Ipos KG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ipos Luneburg?
FDA lists 8 510(k) clearances under the applicant name “Ipos Luneburg” (first 1980, latest 1984), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ipos Luneburg?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ipos Luneburg is 32 days.
Which FDA product codes appear under Ipos Luneburg?
The most frequent FDA product codes under this applicant name are IQI (Orthosis, Limb Brace, 1); ITG (Bandage, Cast, 1); ITO (Twister, Brace Setting, 1).
Next steps
- See all 8 Ipos Luneburg clearances with predicates and recalls
- Run predicate analysis for product code IQI, Ipos Luneburg'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.