Continuum Biomedical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Continuum Biomedical, Inc.” (first 1992, latest 1999), across 1 product code in 1 review panel. Median 510(k) review time under this name: 103 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 19 | 19 |
Review panels
Most recent Continuum Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992013 | DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER | GEX | 1999-09-08 | 85 |
| K983054 | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER | GEX | 1999-02-10 | 162 |
| K973719 | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER | GEX | 1997-12-23 | 84 |
| K970808 | MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER | GEX | 1997-09-05 | 184 |
| K971903 | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER | GEX | 1997-08-21 | 90 |
| K971879 | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER | GEX | 1997-08-14 | 85 |
| K970934 | CB ERBIUM/2.94(TM) ER:YAG LASER | GEX | 1997-06-11 | 90 |
| K963340 | MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE | GEX | 1997-05-12 | 259 |
| K961006 | MEDLITE/755 ALEXANDRITE LASER SYSTEM | GEX | 1996-09-11 | 183 |
| K961748 | MEDLITE/ERBIUM LASER SYSTEM | GEX | 1996-07-26 | 81 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Continuum Biomedical, 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.
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.
- Continuum Electro-Optics, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Continuum Biomedical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Continuum Biomedical, Inc.” (first 1992, latest 1999), across 1 product code 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 Continuum Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Continuum Biomedical, Inc. is 103 days.
Which FDA product codes appear under Continuum Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 19).
Next steps
- See all 19 Continuum Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Continuum Biomedical, 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.