Norland Corp.: FDA clearances and approvals
Norland Corp. has 15 FDA 510(k) clearances (first 1979, latest 1998), across 1 product code in 1 review panel. Median 510(k) review time: 141 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 |
|---|---|---|---|
| KGI | Densitometer, Bone | 15 | 15 |
Review panels
- Radiology (15)
Most recent Norland Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980569 | FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS | KGI | 1998-06-12 | 119 |
| K980289 | FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER | KGI | 1998-06-12 | 137 |
| K980125 | REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER | KGI | 1998-05-20 | 126 |
| K973459 | NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS | KGI | 1998-02-13 | 154 |
| K973104 | NORLAND MODEL PDEXA BONE DENSITOMETER | KGI | 1998-01-29 | 163 |
| K972882 | APOLLO | KGI | 1997-10-31 | 87 |
| K931996 | MODEL PDEXA BONE DENSITOMETER | KGI | 1995-02-01 | 649 |
| K926019 | FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET | KGI | 1994-09-23 | 662 |
| K922286 | MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER | KGI | 1992-11-27 | 196 |
| K913078 | LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET | KGI | 1991-09-24 | 75 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Norland Corp..
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 Norland Corp. have?
Norland Corp. has 15 FDA 510(k) clearances (first 1979, latest 1998), across 1 product code in 1 review panel.
How long does FDA take to clear Norland Corp.'s 510(k)s?
The median time from FDA receipt to decision across Norland Corp.'s cleared 510(k)s is 141 days.
What devices does Norland Corp. make?
Its most frequent FDA product codes are KGI (Densitometer, Bone, 15).
Has Norland Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Norland Corp. Related entities may recall under other names.
Next steps
- See all 15 Norland Corp. clearances with predicates and recalls
- Run predicate analysis for product code KGI, Norland Corp.'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.