Camtronics, Ltd.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Camtronics, Ltd.” (first 1987, latest 2002), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| IZI | System, X-Ray, Angiographic | 3 | 3 |
| LMB | Device, Digital Image Storage, Radiological | 3 | 3 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| LMA | Digitizer, Image, Radiological | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
Review panels
- Radiology (15)
- Cardiovascular (1)
Most recent Camtronics, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021236 | SURGERY AND ACCESSORIES | LLZ | 2002-07-17 | 90 |
| K013032 | PHYSIOLOG, SERIES 95000 | DQK | 2002-06-04 | 267 |
| K992666 | VIDEO PLUS SYSTEM, SERIES 95000 | LLZ | 1999-10-13 | 65 |
| K992259 | ECHOCARDIOGRAPHY SYSTEM SERIES 95000 | LLZ | 1999-09-08 | 64 |
| K990066 | CCD CAMERA, MODEL 9000 | LMA | 1999-03-17 | 68 |
| K955519 | ANALYTICAL REVIEW STATION | IZI | 1996-05-09 | 157 |
| K954159 | DIGITAL IMAGING SYSTEM | LLZ | 1996-03-19 | 196 |
| K955232 | NT SERIES DIGITAL IMAGE MANAGER | LMB | 1995-12-11 | 27 |
| K953080 | DIGITAL IMAGING SYSTEM INTERFACE | LMD | 1995-09-28 | 87 |
| K945654 | NICOM DIGITAL IMAGE MANAGER | LMB | 1995-02-17 | 92 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Camtronics, Ltd..
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.
- Camtronics Medical Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Camtronics, Ltd.?
FDA lists 16 510(k) clearances under the applicant name “Camtronics, Ltd.” (first 1987, latest 2002), across 8 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 Camtronics, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Camtronics, Ltd. is 88 days.
Which FDA product codes appear under Camtronics, Ltd.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 4); IZI (System, X-Ray, Angiographic, 3); LMB (Device, Digital Image Storage, Radiological, 3).
Next steps
- See all 16 Camtronics, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Camtronics, Ltd.'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.