Associated Mills, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Associated Mills, Inc.” (first 1980, latest 1990), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| ILJ | Bath, Hydro-Massage | 2 | 2 |
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| IOG | Treadmill, Mechanical | 1 | 1 |
| IRO | Vibrator, Therapeutic | 1 | 1 |
| IRT | Pad, Heating, Powered | 1 | 1 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
| MCF | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile | 1 | 1 |
Review panels
- Physical Medicine (6)
- Cardiovascular (3)
- Anesthesiology (2)
- General Hospital (2)
- Dental (1)
Most recent Associated Mills, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K901459 | DS60 TOOTHBRUSH SANITIZER | MCF | 1990-09-17 | 173 |
| K872327 | WHIRLPOOL AERATOR WB700, WB800, WB900, WB975 | ILJ | 1987-09-04 | 79 |
| K871661 | WH150 ROOM HUMIDIFIER | KFZ | 1987-06-15 | 48 |
| K862041 | WM10, WM20, WM30 POWER MASSAGER | ISA | 1986-06-17 | 20 |
| K862042 | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER | KFZ | 1986-06-05 | 8 |
| K844397 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 | DSK | 1985-04-18 | 156 |
| K844396 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 | DSK | 1985-04-18 | 156 |
| K850363 | POLLENEX DIGITAL THERMOMETER T-225 | FLL | 1985-02-15 | 16 |
| K850362 | POLLENEX DIGITAL THERMOMETER T-125 | FLL | 1985-02-15 | 16 |
| K841095 | BP800, 850 1000 | DXN | 1984-08-24 | 164 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Associated Mills, 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.
- Associated Medical Products Co. (29 510(k)s)
- Associated Ent., Inc. (4 510(k)s)
- Associated Medical (3 510(k)s)
- Associated Electro-Medical Services, Inc. (2 510(k)s)
- Associated Medical Devices, Inc. (2 510(k)s)
- Associated Electrolysis Group (1 510(k)s)
- Associated Hearing Instruments (1 510(k)s)
- Associated Hospital Services, Inc. (1 510(k)s)
- Associated Medical Representatives (1 510(k)s)
- Associated Premium Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Associated Mills, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Associated Mills, Inc.” (first 1980, latest 1990), across 10 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 Associated Mills, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Associated Mills, Inc. is 48 days.
Which FDA product codes appear under Associated Mills, Inc.?
The most frequent FDA product codes under this applicant name are DSK (Computer, Blood-Pressure, 2); FLL (Continuous Measurement Thermometer, 2); ILJ (Bath, Hydro-Massage, 2).
Next steps
- See all 14 Associated Mills, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSK, Associated Mills, 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.