Alimed, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Alimed, Inc.” (first 1979, latest 1996), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | 3 | 3 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| FNJ | Bed, Manual | 1 | 1 |
| ILH | Splint, Hand, And Components | 1 | 1 |
| IRO | Vibrator, Therapeutic | 1 | 1 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 | 1 |
| KME | Bedding, Disposable, Medical | 1 | 1 |
| KNP | Orthosis, Corrective Shoe | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (5)
- Physical Medicine (3)
- Cardiovascular (1)
- Radiology (1)
Most recent Alimed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963527 | UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS | FMQ | 1996-10-31 | 57 |
| K963528 | ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) | FMQ | 1996-10-29 | 55 |
| K963526 | STRAP WEDGE | FMQ | 1996-10-28 | 54 |
| K920487 | MINI VIBRATOR | IRO | 1992-02-18 | 19 |
| K840156 | PROTECTA COAT SPONGES | IZZ | 1984-03-23 | 70 |
| K822650 | SUPER DONUT | KME | 1982-09-30 | 28 |
| K822651 | TOTAL FINGER FLEXION SPLINT | ILH | 1982-09-17 | 15 |
| K820516 | ARTERIAL CANALIZATION DEVICE | DQY | 1982-04-15 | 49 |
| K820517 | CONSTRUCTA FOAM | — | 1982-03-10 | 13 |
| K801743 | PLASTAZOTE SHOE | KNP | 1980-08-07 | 10 |
1 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-02-12.
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 Alimed, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Alimed, Inc.” (first 1979, latest 1996), across 9 product codes in 4 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 Alimed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alimed, Inc. is 28 days.
Which FDA product codes appear under Alimed, Inc.?
The most frequent FDA product codes under this applicant name are FMQ (Restraint, Protective, 3); DQY (Catheter, Percutaneous, 1); FNJ (Bed, Manual, 1).
Next steps
- See all 11 Alimed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMQ, Alimed, 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.