Products For Medicine: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Products For Medicine” (first 1988, latest 1996), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 1 | 1 |
| FST | Light, Surgical, Fiberoptic | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
| LRT | Indicator, Sterilization | 1 | 1 |
| LYU | Accessory, Surgical Apparel | 1 | 1 |
Review panels
Most recent Products For Medicine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963227 | WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 | GCT | 1996-10-23 | 65 |
| K955510 | X6000D SILENT SUN LIGHT SOURCE | FST | 1996-01-31 | 58 |
| K953089 | I-SPOUSE | LYU | 1995-10-16 | 105 |
| K951704 | NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION | FRG | 1995-06-28 | 77 |
| K951703 | TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS | LRT | 1995-06-28 | 77 |
| K883658 | I-SPOSE EYE SHIELD | FXX | 1988-10-25 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Products For Medicine.
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 Products For Medicine?
FDA lists 6 510(k) clearances under the applicant name “Products For Medicine” (first 1988, latest 1996), across 6 product codes in 3 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 Products For Medicine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Products For Medicine is 71 days.
Which FDA product codes appear under Products For Medicine?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 1); FST (Light, Surgical, Fiberoptic, 1); FXX (Mask, Surgical, 1).
Next steps
- See all 6 Products For Medicine clearances with predicates and recalls
- Run predicate analysis for product code FRG, Products For Medicine'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.