Mr Associates, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Mr Associates, Inc.” (first 1980, latest 1980), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 15 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 |
|---|---|---|---|
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 6 | 6 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 5 | 5 |
| FCC | Endoscopic Magnetic Retriever | 1 | 1 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| FDX | Endoscopic Cytology Brush | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
Review panels
Most recent Mr Associates, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800976 | M.R. ASSOC. W TYPE GRASPING FORCEPS | OCZ | 1980-05-08 | 15 |
| K800975 | M.R. ASSOC. TRUE-FEEL HANDLE | KNS | 1980-05-08 | 15 |
| K800974 | M.R. ASSOC. POWER CORD | KNS | 1980-05-08 | 15 |
| K800973 | M.R. ASSOC. HOT BIOPSY FORCEPS | KNS | 1980-05-08 | 15 |
| K800972 | M.R. ASSOC. TRIPOD GRASPING FORCEPS | OCZ | 1980-05-08 | 15 |
| K800971 | M.R. ASSOC. MAGNETIC EXTRACTOR | FCC | 1980-05-08 | 15 |
| K800970 | M.R. ASSOC. BASKET RETRIEVERS | OCZ | 1980-05-08 | 15 |
| K800969 | M.R. ASSOC. CANNULAS | OCZ | 1980-05-08 | 15 |
| K800968 | M.R. ASSOC. RAT TOOTH GRASP FORCEPS | OCZ | 1980-05-08 | 15 |
| K800967 | M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS | OCZ | 1980-05-08 | 15 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mr Associates, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mr Associates, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Mr Associates, Inc.” (first 1980, latest 1980), across 6 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 Mr Associates, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mr Associates, Inc. is 15 days.
Which FDA product codes appear under Mr Associates, Inc.?
The most frequent FDA product codes under this applicant name are OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered, 6); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 5); FCC (Endoscopic Magnetic Retriever, 1).
Next steps
- See all 15 Mr Associates, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCZ, Mr Associates, 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.