Mill-Rose Laboratory: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “Mill-Rose Laboratory” (first 1979, latest 1998), across 25 product codes in 5 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 11 | 11 |
| GEN | Forceps, General & Plastic Surgery | 6 | 6 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| FCL | Forceps, Biopsy, Non-Electric | 2 | 2 |
| FDI | Snare, Flexible | 2 | 2 |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | 1 | 1 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 | 1 |
| FCK | Instrument, Biopsy, Suction | 1 | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
Plus 15 more product codes.
Review panels
- Gastroenterology and Urology (19)
- General and Plastic Surgery (13)
- Ear, Nose and Throat (12)
- General Hospital (1)
- Pathology (1)
Most recent Mill-Rose Laboratory 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983124 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT | EOQ | 1998-10-30 | 52 |
| K983122 | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT | EOQ | 1998-10-30 | 52 |
| K971275 | MILL-ROSE DISPOSABLE POLYPECTOMY SNARE | FDI | 1997-05-23 | 46 |
| K962736 | MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE | EOQ | 1996-07-29 | 14 |
| K960880 | MILL-ROSE BLIND MICROBIOLOGY BRUSH | EOQ | 1996-04-29 | 56 |
| K954519 | WANG TRANSENDOSCOPIC ASPIRATION NEEDLE | FBK | 1995-12-22 | 85 |
| K951600 | MILL-ROSE ROTATABLE POLYPECTOMY SNARE | FDI | 1995-12-18 | 255 |
| K954745 | MILL-ROSE RIGID SCOPE CLEANING BRUSHES | FEB | 1995-11-27 | 42 |
| K951051 | RITE-BITE BIOPSY FORCEPS | EOQ | 1995-03-24 | 18 |
| K951048 | RITE-BITE BIOPSY FORCEPS | FCL | 1995-03-15 | 9 |
36 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mill-Rose Laboratory.
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.
- Mill-Rose Lab, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mill-Rose Laboratory?
FDA lists 46 510(k) clearances under the applicant name “Mill-Rose Laboratory” (first 1979, latest 1998), across 25 product codes in 5 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 Mill-Rose Laboratory?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mill-Rose Laboratory is 40 days.
Which FDA product codes appear under Mill-Rose Laboratory?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 11); GEN (Forceps, General & Plastic Surgery, 6); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 3).
Next steps
- See all 46 Mill-Rose Laboratory clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Mill-Rose Laboratory'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.