Merlin Engineering Works, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Merlin Engineering Works, Inc.” (first 1995, latest 1998), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
Review panels
- Radiology (8)
Most recent Merlin Engineering Works, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974882 | DOWNSCAN LT | LMD | 1998-05-22 | 143 |
| K971154 | MULTIPICS(ME-977) | LMD | 1997-06-25 | 89 |
| K971153 | SPLITSCREEN (ME-975) | LMD | 1997-06-25 | 89 |
| K970451 | DOWNSCAN 120 | LLZ | 1997-04-07 | 60 |
| K970450 | UPSCAN 120 | LLZ | 1997-04-01 | 54 |
| K954211 | CRISPICS | LLZ | 1995-12-05 | 89 |
| K953398 | UNISCAN | LMD | 1995-10-06 | 78 |
| K933512 | UPSCAN | KPR | 1995-04-19 | 638 |
Recalls
openFDA lists no recalls under a recalling firm named Merlin Engineering Works, 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.
- Merlin Medical Limited (2 510(k)s)
- Merlin Group Dba Mcmerlin Dental Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Merlin Engineering Works, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Merlin Engineering Works, Inc.” (first 1995, latest 1998), across 3 product codes 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 Merlin Engineering Works, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Merlin Engineering Works, Inc. is 89 days.
Which FDA product codes appear under Merlin Engineering Works, Inc.?
The most frequent FDA product codes under this applicant name are LMD (System, Digital Image Communications, Radiological, 4); LLZ (System, Image Processing, Radiological, 3); KPR (System, X-Ray, Stationary, 1).
Next steps
- See all 8 Merlin Engineering Works, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LMD, Merlin Engineering Works, 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.