Douglas James Donaldson Compliance Services: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Douglas James Donaldson Compliance Services” (first 1990, latest 1991), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 90 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 | 2 | 2 |
| HQF | Laser, Ophthalmic | 2 | 2 |
| HGF | Source, Abortion Unit, Vacuum | 1 | 1 |
Review panels
Most recent Douglas James Donaldson Compliance Services 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912987 | CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE | GEX | 1991-10-28 | 112 |
| K912284 | BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF | GEX | 1991-08-19 | 104 |
| K905453 | CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND | HQF | 1991-03-05 | 90 |
| K905115 | BIOVISION ENDOCULAR PROBE | HGF | 1991-02-11 | 90 |
| K904366 | CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR | HQF | 1990-10-19 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Douglas James Donaldson Compliance Services.
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.
- Douglas Medical Products Corp. (20 510(k)s)
- Douglas Scientific Products (2 510(k)s)
- Douglas Bueschel (1 510(k)s)
- Douglas C. Mckee & Co. (1 510(k)s)
- Douglas C. Yoon, Dds (1 510(k)s)
- Douglas Manufacturer Co. (1 510(k)s)
- Douglas Products (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Douglas James Donaldson Compliance Services?
FDA lists 5 510(k) clearances under the applicant name “Douglas James Donaldson Compliance Services” (first 1990, latest 1991), across 3 product codes in 3 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 Douglas James Donaldson Compliance Services?
The median time from FDA receipt to decision across 510(k)s cleared under the name Douglas James Donaldson Compliance Services is 90 days.
Which FDA product codes appear under Douglas James Donaldson Compliance Services?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 2); HQF (Laser, Ophthalmic, 2); HGF (Source, Abortion Unit, Vacuum, 1).
Next steps
- See all 5 Douglas James Donaldson Compliance Services clearances with predicates and recalls
- Run predicate analysis for product code GEX, Douglas James Donaldson Compliance Services'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.