Ferris Mfg. Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Ferris Mfg. Corp.” (first 1978, latest 2005), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | 5 | 5 |
| FRO | Dressing, Wound, Drug | 4 | 4 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 | 2 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| LRS | I.V. Start Kit | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
| NTX | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (14)
- Cardiovascular (2)
- General Hospital (2)
- Neurology (1)
Most recent Ferris Mfg. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031660 | FERRIS POLYMEM STERILE BREAST PAD | NTX | 2005-02-22 | 636 |
| K031307 | FERRIS POLYMEM SILVER WOUND DRESSING | FRO | 2003-10-22 | 181 |
| K002129 | FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN | MGQ | 2000-08-25 | 42 |
| K991729 | FERRIS POLYOSTOMY STERILE WOUND DRESSING | KMF | 1999-08-27 | 99 |
| K990906 | FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER | KMF | 1999-04-29 | 42 |
| K984539 | FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING | KMF | 1999-03-01 | 70 |
| K982306 | POLYTUBE | MGQ | 1998-09-22 | 83 |
| K932913 | FERRIS POLYMEM HYDROPHILIC WOUND DRESSING | KMF | 1994-06-07 | 356 |
| K900127 | FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS) | KMF | 1990-05-18 | 129 |
| K880330 | FERRIS HYDROPHILIC DRESSING | FRO | 1988-03-23 | 56 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ferris Mfg. Corp..
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 Ferris Mfg. Corp.?
FDA lists 20 510(k) clearances under the applicant name “Ferris Mfg. Corp.” (first 1978, latest 2005), across 11 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 Ferris Mfg. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ferris Mfg. Corp. is 78 days.
Which FDA product codes appear under Ferris Mfg. Corp.?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 5); FRO (Dressing, Wound, Drug, 4); DRX (Electrode, Electrocardiograph, 2).
Next steps
- See all 20 Ferris Mfg. Corp. clearances with predicates and recalls
- Run predicate analysis for product code KMF, Ferris Mfg. Corp.'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.