Biometer Intl. A/S: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Biometer Intl. A/S” (first 1986, latest 1993), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 151 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 |
|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | 6 | 6 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 1 | 1 |
Review panels
- Anesthesiology (7)
- Physical Medicine (2)
Most recent Biometer Intl. A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925159 | TOF-GUARD TRANSMISSION MONITOR | KOI | 1993-09-01 | 323 |
| K914231 | ELPHA 2000 | IPF | 1992-05-28 | 251 |
| K892396 | MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR | BXN | 1989-10-03 | 179 |
| K893485 | ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR | BXN | 1989-07-28 | 85 |
| K890746 | MYOTEST DBS NERVE STIMULATOR | BXN | 1989-07-14 | 151 |
| K881196 | AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL | IPF | 1989-06-16 | 452 |
| K870619 | ACCELOGRAPH | BXN | 1987-03-16 | 32 |
| K860187 | MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING | BXN | 1986-03-20 | 57 |
| K860186 | MYOTEST - NERVE STIMULATOR | BXN | 1986-03-20 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Biometer Intl. A/S.
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 Biometer Intl. A/S?
FDA lists 9 510(k) clearances under the applicant name “Biometer Intl. A/S” (first 1986, latest 1993), across 3 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 Biometer Intl. A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biometer Intl. A/S is 151 days.
Which FDA product codes appear under Biometer Intl. A/S?
The most frequent FDA product codes under this applicant name are BXN (Stimulator, Nerve, Battery-Powered, 6); IPF (Stimulator, Muscle, Powered, 2); KOI (Stimulator, Nerve, Peripheral, Electric, 1).
Next steps
- See all 9 Biometer Intl. A/S clearances with predicates and recalls
- Run predicate analysis for product code BXN, Biometer Intl. A/S'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.